Catalog Number

-

Brand Name

AMG

Version/Model Number

ALC0001XXL

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"

-

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

1d034418-a7b7-4791-8364-b4b4b53e484b

Public Version Date

August 14, 2020

Public Version Number

1

DI Record Publish Date

August 06, 2020

Package DI Number

10850017650791

Quantity per Package

3

Contains DI Package

00850017650794

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case