Catalog Number

8036-

Brand Name

Curity

Version/Model Number

8036

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)

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

518c7efe-fe13-4813-a4a8-2d0b7cb87451

Public Version Date

September 03, 2020

Public Version Number

1

DI Record Publish Date

August 26, 2020

Package DI Number

50192253024430

Quantity per Package

12

Contains DI Package

10192253024432

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE