Catalog Number

LLG800

Brand Name

AMBITEX

Version/Model Number

LLG800

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 31, 2020

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)

Yes

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

LYY

Product Code Name

Latex patient examination glove

Public Device Record Key

833d4918-7c03-4e95-acb4-3b4a5bd5b81c

Public Version Date

March 31, 2020

Public Version Number

3

DI Record Publish Date

April 22, 2019

Package DI Number

10699320102142

Quantity per Package

10

Contains DI Package

00699320102145

Package Discontinue Date

March 31, 2020

Package Status

Not in Commercial Distribution

Package Type

CASE