Integra® Dermal Regeneration Template Single Layer
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INTEGRA® Dermal Regeneration Template Single Layer is an advanced wound care device comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan for dermal regeneration. IDRT-SL template can be used:
- In a one-stage procedure with the epidermal graft at the same time for appropriate wounds.
- In a two-stage procedure in combination with the IDRT-TS template (bilayer) for deep wounds.
INTEGRA® Dermal Regeneration Template is indicated for the postexcisional treatment of full-thickness and partial-thickness injuries where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient.
INTEGRA® Dermal Regeneration Template is also indicated for use in reconstruction of postexcisional, full-thickness defects of the integument where there is, in the opinion of the treating surgeon, a potential benefit to the patient by improving the reconstructive outcome or decreasing their mortality/morbidity.
Use of INTEGRA® Dermal Regeneration Template is contraindicated in patients with known hypersensitivity to bovine collagen, chondroitin or silicone materials. INTEGRA template should not be used on clinically diagnosed infected wounds.
- Each sheet of INTEGRA template is packaged in phosphate buffer in a foil pouch. Each foil pouch is packaged in a sealed outer chevron-style pouch.
- Store flat at +2º to +30ºC.
- Protect from freezing.
- Once the product packaging has been opened, the product cannot be stored for reuse.
- Please refer to the clinical training materials for complete instructions.
|62021||IDRT-SL 5cm x 5cm||1 sheet|
|64051||IDRT-SL 10cm x 12,5cm||1 sheet|
|64101||IDRT-SL 10cm x 25cm||1 sheet|
|68101||IDRT-SL 20cm x 25cm||1 sheet|
Regulatory and Legal Information
Integra LifeSciences Corporation
311 Enterprise Drive
Plainsboro • NJ 08536 • USA
Integra LifeSciences Services (France) SAS
Immeuble Sequoia 2 • 97 allée Alexandre Borodine
Parc technologique de la Porte des Alpes
69800 Saint Priest • FRANCE
Phone: +33 (0)4 37 47 59 00 • fax: +33 (0)4 37 47 59 99
Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country
• Always refer to the appropriate instructions for use for complete clinical instructions.
• Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.
• WARNING: Applicable laws restrict these products to sale by or on the order of a physician.
Products mentioned in this document are CE class III devices. Please read carefully the instructions for use. All the medical devices mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.
Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. ©2016 Integra LifeSciences Corporation. All rights reserved. Last modifcation date: 01/2016. XXXXXXX-1-EN Document for use in Europe, Middle-East & Africa only.
For complete product information, please see the Instructions for Use accompanying each product.