Catalog Number

-

Brand Name

AmerisourceBergen

Version/Model Number

10911

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

K112266,K112266,K112266

Product Code

LYZ

Product Code Name

Vinyl Patient Examination Glove

Public Device Record Key

3af71da7-fa90-4c68-8e47-0cae2e00fc42

Public Version Date

July 18, 2022

Public Version Number

1

DI Record Publish Date

July 08, 2022

Package DI Number

60368001109118

Quantity per Package

10

Contains DI Package

00368001109116

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case