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Clarix 1K
Clarix 1K is a cryopreserved ultra-thick amniotic membrane allograft derived from umbilical cord, used for the management of non-healing and chronic wounds.
BioTissue Surgical
BioTissue Surgical is a pioneer in human birth tissue applications as an adjunct in the treatment of surgical and chronic wounds.
2cmx1cm, 2cmx2cm, 3cmx2cm, 3cmx3cm, 4cmx3cm, 6cmx3cm, 8cmx3cm
· For over 36 years, our pioneering scientists have focused on understanding the regenerative features of human birth tissue—ultimately identifying HC-HA/PTX3 as a key orchestrator in human birth tissue regenerative healing.
· Our CryoTek® cryopreservation process has been shown to preserve the structural and functional integrity of the HC-HA/PTX3—delivering the benefits of the natural tissue to the wound.
· BioTissue® Surgical human birth tissue products are aseptically processed, devascularized and cell devitalized to deliver the innate properties of human birth tissue to the wound environment.
CLARIX 1K can be used as a barrier or cushion to create a protective environment for healing to occur when used in surgical soft tissue repair and reconstruction.
· Do not use if packaging is damaged. Do not use on patients with a history of drug reactions to Amphotericin B. Do not sterilize or re-sterilize. It is imperative that the allograft is properly stored.
· CLARIX 1K exposed to controlled room temperature (20°C to 25°C, 68°F to 77°F) for up to 6 hours may be returned to cold temperature storage in accordance with the Storage requirements as long as the packaging remains unopened and intact.
· Once the outer foil pouch is opened, CLARIX 1K shall either be transplanted or otherwise discarded. Do not sterilize or autoclave the product before use.
Shelf life is two years from date of manufacture. Can be stored in a standard refrigerator or freezer at specified temperatures and specified times -80°C–4°C (-112°F–39.2°F) Example: ultra-low temperature freezer, standard freezer, or standard refrigerator within the expiration date printed on product. It is the responsibility of the tissue dispensing service, tissue distribution intermediary, and/or end-user clinician to maintain tissue intended for transplantation in appropriate storage.
1. If frozen, allow CLARIX 1K to sit at controlled room temperature(20°C to 25°C) in its original unopened packaging for at least 5 minutes.
2. Open the outer foil peel pouch and present the clear inner pouch to the sterile field using aseptic techniques.
3. Open the clear inner peel pouch to retrieve CLARIX 1K.
4. The product may be rinsed in sterile saline or water prior to application.
5. Secure CLARIX 1K onto the surgical site
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