Medical Device Qualified Supplier Directory
Qualifications: ISO 13485, FDA Registered, Supplier to Medical Manufacturers
Markets Supplied: North America, Europe
CleanCut Technologies is an FDA registered and ISO 13485 certified medical device packaging company located in Anaheim, California. Our products are manufactured in Class 7 (10,000) & Class 8 (100,000) certified facilities with full traceability. CleanCut offers the following products and services: HDPE Pouch Cards, patented Clipless Catheter Dispensers, Tyvek Pouches & Lids, Cartons & Shippers, Free Design & Prototyping, 3D printing, Tube Flaring, Pad Printing and Contract Packaging services.
We ensure that you meet critical deadlines with:
- Innovative designs and turnkey prototype samples - typically within five working days
- Feasibility validation samples before production tooling
- Cost-effective tooling and production runs certified with full QSR/ISO traceability to raw materials
Clipless Dispensers: Clipped dispensers for coiled guidewire and catheter retention and dispensing generate excessive waste, packaging bulk, and have the potential to break free during shipping and use in the OR. CleanCut Technologies’ award-winning patented one-piece Clipless Dispenser addresses these challenges with a sleek, slim and symmetrical design that is optimized for retention of a device during shipping, storage and ease of use during surgical procedures. The Clipless Dispenser material is pre-qualified for biocompatibility using HDPE and PP tubing following 2Xs 100% EtO and Gamma sterilization, and has passed three years of real-time aging. The tubing may be manufactured in various sizes and lengths from 15” to 217” to accommodate any guidewire or catheter size, and is thermally bonded for superior security without clips or adhesives. CCT also designs and supplies custom luer retention elements which ensure products are packaged safe and secure without damage.
DISK: For a complete all-in-one packaging system, our Dispenser Integrated System Kit (DISK) includes a Clipless Dispenser thermally bonded to an HDPE card to provide additional retention and packaging of procedurally related components such as syringes, luers, and needles. Our Clipless Dispensers are manufactured in our Class 100,000 (Class 8) cleanroom, and then transported into our Class 10,000 (Class 7) cleanroom for additional assembly, cleaning, inspection, double polybagging and labeling.
Dual Hoop Catheter DISK: Looking to eliminate additional catheter and guidewire packaging? The DISK has been further enhanced by adding a second coiled hoop to the HDPE backer card. This entirely new packaging solution for distributing different size catheters in one system, eliminates the need for additional catheter packaging and significant cost savings are realized. The DISK reduces packaging, waste, time and shelf space.
HDPE Pouch Cards: Whether you are looking for a cost-effective alternative to a thermoformed tray, or considering a HDPE pouch card insert to safely and securely retain devices within a tray – CleanCut’s custom, die-cut High Density Polyethylene (HDPE) pouch cards are the ideal packaging solution for both. With almost limitless retention elements and design flexibility, pouch cards are manufactured to your device’s unique requirements while creating an efficient and cost-effective packaging solution. Pouch cards can be manufactured in lengths from 2” to 74” in various gauges and colors. Material is validated for biocompatibility per ISO 10993 following EtO and gamma sterilization.
Quick Tray with Pop 'N' Lock Technology: The new Quick Tray with Pop ‘N Lock Technology is a pouch card designed to give medical device manufacturers a packaging solution that offers strength, rigidity and stability without having to utilize rigid packaging materials. By manufacturing an HDPE pouch card with reinforced side rails, and using our easy Pop ‘N Lock Technology, the enhanced pouch card now becomes a sturdy Quick Tray for heavy or light devices.
Easy Loading Fixture or ELF™: The ELF is a time-saving fixture designed to reduce assembly time and increase output for medical device manufacturers. It is a custom-designed fixture that simultaneously releases retention elements on a pouch card within seconds. Without the need for assembly teams to perform this manually, medical device manufacturers can expect their output to increase significantly.
The ELF is not only durable, but exceptionally easy to use. Simply place the pouch card in the ELF, close the lid and push the handles. The ELF is custom-designed to the exact specifications of your device, which allows the pins within the ELF fixture, to accurately push all retention elements in place.
Medical devices can be conveniently loaded on the pouch card either inside, outside or on top of the ELF. The pouch card is then easily removed with devices safely and securely in place.
Pouches & Tyvek Lids: Pouch-style packaging gives medical device manufacturers a superior flexible sterile barrier to protect their devices. CleanCut Technologies offers Tyvek® material, along with validated polymers and other materials for exceptional breathability and repeatable, reliable clean-peel pouch performance. The innovative structure of Tyvek® resists microbial penetration and has the flexible strength to guard against punctures from the device it’s retaining. CCT’s pouches are manufactured with precision and reliability to your exact specifications. Our servo-controlled machines produce a consistent repeatable seal, time after time. Our validated equipment has fully-adjustable rollers and sealing controls, eliminating the need for customer tooling. Pouches can be manufactured up to 18” wide by 80” long without dual seal overlaps, which can sometimes lead to burn-through and other quality issues. We offer custom in-line pouch printing for a cleaner-looking pouch, finished in the same amount of time it takes to produce a plain pouch. Printing artwork up to 36” long directly on a Tyvek pouch versus a printed label improves branding and saves significant material and labor costs. We provide quick-turn printing requests and rapid design changes on pouches up to 80” long with non-overlapping seals.
SBS Cartons & Shippers: CleanCut Technologies designs and offers precisely sized and complimentary SBS shelf cartons and corrugated sterilization master cartons for a total end-to-end packaging solution. All cartons are designed to reduce material footprints and can be ordered plain or with custom printed graphics and logos resulting in unique product branding. We specialize in the “hard to find” cartons ranging from 4” up to 80” in length with the controls and traceability expected from the medical device industry.
Design & Prototyping: The packaging elements of your medical device play a critical role in the safety and usability of the device. Inferior packaging could lead to device damage or contamination. Trust CleanCut Technologies to design innovative, efficient, safe and sterile protection for the device you’ve worked so hard to create. How does the process work? First, we’ll hold an initial information-gathering design input meeting to learn about your device and specific packaging requirements. If your device is still in the concept-stage, no problem! We are able to create 3D prototype samples in-house based on your CAD drawings, which allow us to begin designing your packaging before the actual device is even realized. Once we have output the initial CAM designs for your review, modifications can be made as required until the package design is exactly how you want it. Following initial approval, we can rapidly generate prototype samples for your final evaluation – usually within five working days. Once approved, development samples can be ordered to validate shipping, sterilization and final product realization requirements. Once these requirements are met, production tooling is built, first articles are submitted to you, and production begins.
3D Printing: Even if your device is still in the CAD drawing concept-stage, CleanCut Technologies can start designing the packaging elements for it, putting you ahead of the game. We create exceptionally accurate 3D product packaging models with our in-house 3D printer. 3D sampling for product fit verification is produced using materials such as ABS or Ultem, and we can reliably provide samples based on a customer’s confidential electronic files within 48 to 72 hours. If a project requires prototype tooling or sampling, we can produce 3D printed temporary tooling for small run jobs, instead of waiting weeks for a third-party vendor. Tooling for packaging may require multiple fixtures, and printing a tool or fixture in-house saves time - ultimately providing customers near-immediate product samples with a realistic look and feel for packaging design review.
Tube Flaring, Drilling & Skiving Services: CleanCut Technologies offers high-quality tube flaring, drilling and skiving services. Flared tube ends provide an atraumatic entry for catheters and coated guidewires plus security of luers and strain relief for various devices, and reduces cost by routinely eliminating the need for expensive secondary components for product retention. CleanCut’s hole drilling and skiving services produce perfectly-spaced and burr-free cuts time after time.
Pad Printing: Pad printing is a process that transfers a 2D image onto a 3D object with a silicone pad and ink. Most medical devices require some form of pad printing for labeling, measurement indicators, part identification or branding information. Pad printing is an inexpensive process that yields consistent, high-quality results. Due to complicated sizes, shapes, or difficult surface materials like Silicone, Polypropylene or Polyethylene, some complex medical devices pose a challenge to print on accurately and cleanly. CleanCut Technologies offers superior pad printing for the most strictly-regulated class of medical devices in the industry. Printing is done with USP Class VI medical grade inks in Class 8 cleanroom using stringent FDA and ISO controls.
Contract Manufacturing: Need a little help? CleanCut Technologies is experienced and equipped to handle contract manufacturing projects, big or small. Our outsourcing services include: packaging concept generation, packaging design development, packaging design verification, process development, process validation/implementation and fulfillment.
We invite you to tour our Southern California facility and see first-hand our innovations in medical device packaging.
Call us at 714-864-3500 or email [email protected].
1145 N. Ocean Circle
Anaheim CA 92806
For more information contact CleanCut Technologies, LLC