Catalog Number

GDN22024

Brand Name

AMBITEX

Version/Model Number

GDN22024

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2019

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

LZA

Product Code Name

Polymer patient examination glove

Public Device Record Key

32f25939-b77f-4204-8b8e-7046fbc460fa

Public Version Date

September 30, 2019

Public Version Number

3

DI Record Publish Date

April 11, 2019

Package DI Number

20699320452008

Quantity per Package

24

Contains DI Package

00699320452004

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

CASE