Catalog Number

66801174

Brand Name

DURAFIBER Ag 10x10cm

Version/Model Number

66801174

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

e56c73be-c98a-45a5-8cdd-3d950615e4c8

Public Version Date

July 22, 2021

Public Version Number

2

DI Record Publish Date

October 23, 2020

Package DI Number

05000223480226

Quantity per Package

10

Contains DI Package

05000223467418

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton