Catalog Number

-

Brand Name

AMG

Version/Model Number

SCS001U

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

BWP

Product Code Name

Shoe And Shoe Cover, Conductive

Public Device Record Key

dda6e2dc-0955-4873-bd1b-2ba0aa69d48f

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

June 22, 2020

Package DI Number

20850017650064

Quantity per Package

10

Contains DI Package

00850017650060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case