Catalog Number

-

Brand Name

AMG

Version/Model Number

SP001L

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

992534bc-8bd2-498b-aa53-6addfa311475

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

November 06, 2020

Package DI Number

10850017650982

Quantity per Package

6

Contains DI Package

00850017650985

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case