Catalog Number

-

Brand Name

AMG

Version/Model Number

SP001M

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

c0924919-ba3d-4aa1-9d35-368bc6629213

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

July 23, 2020

Package DI Number

10850017650586

Quantity per Package

6

Contains DI Package

00850017650589

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case