Catalog Number

5030030U0

Brand Name

GEM

Version/Model Number

5030030U0

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

-

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

EGZ

Product Code Name

Holder, Film, X-Ray

Public Device Record Key

9b0f2575-b6de-41bd-a959-aa1a550be9c7

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 14, 2022

Package DI Number

10618125190680

Quantity per Package

500

Contains DI Package

00887919949138

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box