INTEGRA Matrix Wound Dressing - INTEGRA Matrix Wound Dressing is an advanced - Integra Lifesciences Corporation

Duns Number:083171244

Device Description: INTEGRA Matrix Wound Dressing is an advanced wound care device comprised of a porous matri

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

54101

Brand Name

INTEGRA Matrix Wound Dressing

Version/Model Number

54101

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"

-

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

K022127

Product Code Details

Product Code

KGN

Product Code Name

DRESSING, WOUND, COLLAGEN

Device Record Status

Public Device Record Key

48aa909e-d545-4944-8ebe-b0c5fcaebfd2

Public Version Date

September 22, 2020

Public Version Number

5

DI Record Publish Date

September 23, 2015

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