Catalog Number

-

Brand Name

AMG

Version/Model Number

AMF2103-L3

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 10, 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

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

e425fc74-f4fc-47d9-b33e-80fe8ee83812

Public Version Date

July 20, 2020

Public Version Number

2

DI Record Publish Date

June 22, 2020

Package DI Number

10850017650364

Quantity per Package

8

Contains DI Package

00850017650367

Package Discontinue Date

July 10, 2020

Package Status

Not in Commercial Distribution

Package Type

Case