Amalgatome MD Excision Ring Blade Update
- AMD BLADE X100457
Please review the following announcements regarding updates to the ball strip material and packaging:
- The ball bearing strip color and material are changing from WHITE to BLUE. No additional components of the blade material or design are impacted.
- The material was changed from Acetal to a medical grade Nylon to allow for product to be sterilized via gamma radiation.
- All required material compatibility testing for this including sterilization and bio-compatibility has been performed and on file.
- There is no impact to the Amalgatome MD product performance as a result of this change.
- Peel Pouch. You will find the pouch is a high-density poly peel pouch that is vacuumed sealed. This pouch allows for greater protection of the inside contents and helps to reduce any visual imprints on the pouch from the inside edges.
- Clamshell Protective Housing. The entire blade is now protected by a circular plastic tray to house the sharp blade edge and teeth.
- This way the entire blade is encapsulated within the clamshell to offer greater protection from the blade edge as well as the teeth from imprinting on the pouch.
- Yellow Safety Sticker. The yellow caution sticker has been added as an additional warning for the internal contents of the clamshell. It is a visual guide for staff to follow when opening the clamshell using aseptic technique.
- Please review the attached PDF's on the change notification