Catalog Number

-

Brand Name

Amerisource Bergen

Version/Model Number

10906

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

K131832,K131832,K131832

Product Code

LYZ

Product Code Name

Vinyl Patient Examination Glove

Public Device Record Key

0375c8b6-da60-427b-a957-8e3db73334a0

Public Version Date

April 15, 2022

Public Version Number

2

DI Record Publish Date

March 04, 2022

Package DI Number

60368001109064

Quantity per Package

10

Contains DI Package

00368001109062

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case