Catalog Number

LLG240

Brand Name

AMBITEX

Version/Model Number

LLG240

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 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)

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

K051404,K093375,K051404,K093375,K051404,K093375

Product Code

LYY

Product Code Name

Latex patient examination glove

Public Device Record Key

5a5bf798-d48c-4332-b2aa-c96a89aa597b

Public Version Date

December 02, 2019

Public Version Number

3

DI Record Publish Date

April 05, 2019

Package DI Number

10699320107949

Quantity per Package

10

Contains DI Package

00699320107942

Package Discontinue Date

November 30, 2019

Package Status

Not in Commercial Distribution

Package Type

CASE