Catalog Number

-

Brand Name

Custom Healthcare Systems Inc.

Version/Model Number

D5-10723

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

5e758561-98da-491f-b693-76b07b0bce5f

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

July 26, 2018

Package DI Number

20811870030332

Quantity per Package

50

Contains DI Package

00811870030338

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

N/A