INTEGRA® - INTEGRA Meshed Dermal Regeneration Template 2in. - Integra Lifesciences Corporation

Duns Number:083171244

Device Description: INTEGRA Meshed Dermal Regeneration Template 2in. x 2in. (5cm x 5cm), an Integra template a INTEGRA Meshed Dermal Regeneration Template 2in. x 2in. (5cm x 5cm), an Integra template available in a Meshed configuration, 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.

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More Product Details

Catalog Number

MDRT2021

Brand Name

INTEGRA®

Version/Model Number

MDRT2021

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P900033

Product Code Details

Product Code

MDD

Product Code Name

DEVICE, DERMAL REPLACEMENT

Device Record Status

Public Device Record Key

b3d4686d-4ef5-43aa-a537-1ee5cf1603cc

Public Version Date

October 25, 2022

Public Version Number

7

DI Record Publish Date

September 05, 2014

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTEGRA LIFESCIENCES CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14
2 A medical device with a moderate to high risk that requires special controls. 75
3 A medical device with high risk that requires premarket approval 17
U Unclassified 32