Catalog Number

AG4416X

Brand Name

ALLCARE

Version/Model Number

AG4416X

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

GDY

Product Code Name

Gauze/Sponge, Internal, X-Ray Detectable

Public Device Record Key

4f63bdf6-4b78-4c0e-b7c0-64b690b9379a

Public Version Date

June 13, 2022

Public Version Number

1

DI Record Publish Date

June 05, 2022

Package DI Number

10182921000110

Quantity per Package

2000

Contains DI Package

00182921000540

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case