Home GUDID M269340551 INTEGRA Dermal Regeneration Template (Terminally Sterilized)
Primary DI M269340551
Brand INTEGRA Dermal Regeneration Template (Terminally Sterilized)
Company Integra Lifesciences Corporation
Model 34055
Catalog number 34055
Device description INTEGRA Dermal Regeneration Template 4in. x 5in. (10cm x 12.5cm) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and a glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound.
Published 2014-09-05
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name MGR Dressing, Wound And Burn, Interactive
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MGR Dressing, Wound And Burn, Interactive Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10381780000570 Primary GS1 0 M269340551 Secondary HIBCC 0 00381780000573 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10381780000570 10381780000570 00381780000573 00381780000573 381780000573 0381780000573
GMDN Terms# Term, Definition table Term Definition Skin regeneration template, human-/animal-derived A sterile covering used as a temporary skin substitute on wounds (e.g., diabetic or venous insufficiency ulcers) or burns that involve the dermis, and that provides a matrix, typically of living cells (fibroblasts) and/or structural proteins, to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device contains human- and animal-derived products (e.g., bovine, porcine), or only animal-derived products. It may be mono- or bi-layered, and may contain natural and synthetic materials. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 2 Degrees Celsius 30 Degrees Celsius Special Storage Condition, Specify 0 0 Store Flat
Regulatory Flags# DUNS number 083171244 Device count 5 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00618474000046 TransCyte ORGANOGENESIS INC. MGR 2018-01-12 10381780258872 Omnigraft™ Integra Lifesciences Corporation MGR 2017-02-01 10381780125785 Omnigraft™ Integra Lifesciences Corporation MGR 2016-05-11 10381780000549 Integra® Dermal Regeneration Template Integra Lifesciences Corporation MGR 2014-09-05 10381780000556 Integra® Dermal Regeneration Template Integra Lifesciences Corporation MGR 2014-09-05 10381780000563 Integra® Dermal Regeneration Template Integra Lifesciences Corporation MGR 2014-09-05 10381780000570 Integra® Dermal Regeneration Template Integra Lifesciences Corporation MGR 2014-09-05 10381780000587 Integra® Dermal Regeneration Template Integra Lifesciences Corporation MGR 2014-09-05 10381780000594 Integra® Dermal Regeneration Template Integra Lifesciences Corporation MGR 2014-09-05 10381780000600 Integra® Dermal Regeneration Template Integra Lifesciences Corporation MGR 2014-09-05 10381780000617 Integra® Dermal Regeneration Template Integra Lifesciences Corporation MGR 2014-09-05 10381780000624 Integra® Integra Lifesciences Corporation MGR 2014-09-05 10381780000631 Integra® Integra Lifesciences Corporation MGR 2014-09-05 10381780000648 Integra® Integra Lifesciences Corporation MGR 2014-09-05 10381780000655 Integra® Integra Lifesciences Corporation MGR 2014-09-05 M269320211 INTEGRA Dermal Regeneration Template (Terminally Sterilized) Integra Lifesciences Corporation MGR 2014-09-05 M269320251 INTEGRA Dermal Regeneration Template (Terminally Sterilized) Integra Lifesciences Corporation MGR 2014-09-05 M269340511 INTEGRA Dermal Regeneration Template (Terminally Sterilized) Integra Lifesciences Corporation MGR 2014-09-05 M269341011 INTEGRA Dermal Regeneration Template (Terminally Sterilized) Integra Lifesciences Corporation MGR 2014-09-05 M269341051 INTEGRA Dermal Regeneration Template (Terminally Sterilized) Integra Lifesciences Corporation MGR 2014-09-05 M269381011 INTEGRA Dermal Regeneration Template (Terminally Sterilized) Integra Lifesciences Corporation MGR 2014-09-05 M269381051 INTEGRA Dermal Regeneration Template (Terminally Sterilized) Integra Lifesciences Corporation MGR 2014-09-05 M269MDRT20211 INTEGRA Meshed Dermal Regeneration Template Integra Lifesciences Corporation MGR 2014-09-05 M269MDRT40511 INTEGRA Meshed Dermal Regeneration Template Integra Lifesciences Corporation MGR 2014-09-05 M269MDRT41011 INTEGRA Meshed Dermal Regeneration Template Integra Lifesciences Corporation MGR 2014-09-05 M269MDRT81011 INTEGRA Meshed Dermal Regeneration Template Integra Lifesciences Corporation MGR 2014-09-05
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