Catalog Number

AG4412

Brand Name

AllCare

Version/Model Number

AG4412

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

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

8a303a37-37ed-4200-a07f-f109ca94d5a3

Public Version Date

May 23, 2022

Public Version Number

2

DI Record Publish Date

April 06, 2022

Package DI Number

00182921000045

Quantity per Package

10

Contains DI Package

10182921000127

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case