Catalog Number

-

Brand Name

Tubigrip®

Version/Model Number

1545

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

-

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

20dec7fa-1043-46f1-ad1f-d3a1752c14e2

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 21, 2022

Package DI Number

07332551946111

Quantity per Package

5

Contains DI Package

05055158005778

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE