Catalog Number

-

Brand Name

Amerisource Bergen

Version/Model Number

10012

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2022

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

e3cbf3ea-1866-4c28-81e6-abebeff56839

Public Version Date

September 07, 2022

Public Version Number

3

DI Record Publish Date

November 18, 2021

Package DI Number

60368001100122

Quantity per Package

10

Contains DI Package

00368001100120

Package Discontinue Date

June 30, 2022

Package Status

Not in Commercial Distribution

Package Type

Case