Catalog Number

-

Brand Name

AMG

Version/Model Number

2023

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 15, 2020

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

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

27adbfcd-e2f6-48e7-9fee-080e7ad46192

Public Version Date

June 23, 2020

Public Version Number

2

DI Record Publish Date

June 12, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-