BioPatch™ - BioPatch™ Antimicrobial Dressing with - Integra Lifesciences Corporation

Duns Number:083171244

Device Description: BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyuretha BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane absorptive foam with Chlorhexidine Gluconate (CHG) which inhibits bacterial growth under the dressing. The dressing is intended to be used to absorb exudate, cover a wound caused by vascular and nonvascular percutaneous medical devices during surgery, as well as reduce local infection and colonization of microorganisms.

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More Product Details

Catalog Number

-

Brand Name

BioPatch™

Version/Model Number

44151

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

Yes

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

-

FDA Premarket Submission

K003229,K003229,K003229

Product Code Details

Product Code

FRO

Product Code Name

Dressing, wound, drug

Device Record Status

Public Device Record Key

253a8207-c17f-4363-aaba-c76f6cf501d0

Public Version Date

September 22, 2020

Public Version Number

6

DI Record Publish Date

June 20, 2016

Additional Identifiers

Package DI Number

30705031132904

Quantity per Package

4

Contains DI Package

20705031132907

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"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