Catalog Number

-

Brand Name

Custom Healthcare Systems Inc.

Version/Model Number

D4-4MCV

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)

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

eed56d97-82eb-4d36-941b-1fb12ff02422

Public Version Date

August 30, 2018

Public Version Number

1

DI Record Publish Date

July 30, 2018

Package DI Number

20811870030295

Quantity per Package

30

Contains DI Package

00811870030291

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

N/A