Catalog Number

-

Brand Name

Sensi-Wrap, Self Adherent

Version/Model Number

3303

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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)

-

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

bdff3361-35dd-491a-abf7-14801aec6cac

Public Version Date

September 09, 2021

Public Version Number

1

DI Record Publish Date

September 01, 2021

Package DI Number

00616784330327

Quantity per Package

24

Contains DI Package

00616784330310

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box