Catalog Number

AG4416X-10

Brand Name

AllCare

Version/Model Number

AG4416X-10

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

18449249-764c-4b2e-9aa7-c193d3b69410

Public Version Date

May 23, 2022

Public Version Number

3

DI Record Publish Date

September 23, 2020

Package DI Number

30182921000091

Quantity per Package

128

Contains DI Package

00182921000090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-