Catalog Number

-

Brand Name

HCS

Version/Model Number

HCS5033-411S

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"

Yes

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

FQM

Product Code Name

Bandage, Elastic

Public Device Record Key

d01491bc-eaec-4b89-8b86-ea643f3aa226

Public Version Date

September 20, 2021

Public Version Number

2

DI Record Publish Date

January 31, 2021

Package DI Number

10849027005035

Quantity per Package

20

Contains DI Package

00849027005038

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case