Catalog Number

AL1818R

Brand Name

AllCare

Version/Model Number

AL1818R

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

95b25c5f-8c8f-4ef1-9835-13b7e919989f

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

September 23, 2020

Package DI Number

30182921000602

Quantity per Package

40

Contains DI Package

00182921000601

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-