Catalog Number

66800571

Brand Name

DURAFIBER Ag 10x12cm

Version/Model Number

66800571

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K161289,K161289,K161289

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

36bd1385-9ed2-4bed-bf0e-382598943f48

Public Version Date

July 22, 2021

Public Version Number

2

DI Record Publish Date

September 18, 2020

Package DI Number

05000223467906

Quantity per Package

10

Contains DI Package

05000223467890

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton