Catalog Number

-

Brand Name

Custom Healthcare Systems, Inc.

Version/Model Number

D21-9064

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

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

e9a6abe3-88ed-420e-b2ed-408738fc70cb

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

November 30, 2020

Package DI Number

20811870035368

Quantity per Package

100

Contains DI Package

00811870035364

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

NA