Catalog Number

66000701, 66000047

Brand Name

Profore WCL 14 x 20cm

Version/Model Number

66000701, 66000047

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

-

Product Code

NAB

Product Code Name

Gauze / Sponge,Nonresorbable For External Use

Public Device Record Key

15ae711b-7a9e-49b7-8d5f-479dd2f05045

Public Version Date

June 22, 2021

Public Version Number

4

DI Record Publish Date

April 09, 2020

Package DI Number

05000223441906

Quantity per Package

50

Contains DI Package

05000223440480

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton 66000701