Catalog Number

-

Brand Name

Exufiber® Ag+

Version/Model Number

603425

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K160379,K160379,K160379

Product Code

FRO

Product Code Name

Dressing, wound, drug

Public Device Record Key

4bd29bca-56f7-44fe-be8c-18e4037c7c72

Public Version Date

July 22, 2021

Public Version Number

2

DI Record Publish Date

January 27, 2021

Package DI Number

07323190152759

Quantity per Package

6

Contains DI Package

07323190152766

Package Discontinue Date

December 31, 1995

Package Status

Not in Commercial Distribution

Package Type

-