Catalog Number

-

Brand Name

AmerisourceBergen

Version/Model Number

10023

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"

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

e9d0ad14-c062-4c8d-b122-e1d4625e2331

Public Version Date

November 26, 2021

Public Version Number

1

DI Record Publish Date

November 18, 2021

Package DI Number

60368001100238

Quantity per Package

10

Contains DI Package

00368001100236

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case