Catalog Number

NLG350

Brand Name

AMBITEX

Version/Model Number

NLG350

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 02, 2021

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

bef7ae28-8e6a-4b2f-8f1e-c79ad1fddaf6

Public Version Date

August 03, 2021

Public Version Number

3

DI Record Publish Date

May 15, 2020

Package DI Number

10699320000691

Quantity per Package

10

Contains DI Package

00699320000694

Package Discontinue Date

August 02, 2021

Package Status

Not in Commercial Distribution

Package Type

CASE