Catalog Number

-

Brand Name

AD Surgical

Version/Model Number

GZE-S3

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

63682104-78fb-44c1-aa6c-dedb99999a91

Public Version Date

August 24, 2021

Public Version Number

3

DI Record Publish Date

May 24, 2017

Package DI Number

20814639023484

Quantity per Package

24

Contains DI Package

10814639023487

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case