Catalog Number

3616

Brand Name

Curity

Version/Model Number

3616

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)

-

Over the Counter (OTC)

Yes

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

660f4268-1077-4b0e-9896-22b62169e08a

Public Version Date

December 08, 2021

Public Version Number

4

DI Record Publish Date

June 30, 2018

Package DI Number

20884527015754

Quantity per Package

144

Contains DI Package

10884527015757

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE