Catalog Number

NMD200G

Brand Name

AMBITEX

Version/Model Number

NMD200G

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"

-

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

3740c47b-e515-4784-8cb6-a4c1e0796141

Public Version Date

September 10, 2021

Public Version Number

1

DI Record Publish Date

September 02, 2021

Package DI Number

10699320000158

Quantity per Package

10

Contains DI Package

00699320000151

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE