Catalog Number

28959

Brand Name

Telfa

Version/Model Number

28959

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"

-

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

NAD

Product Code Name

Dressing, wound, occlusive

Public Device Record Key

d5e3e589-5115-4582-8152-75c943aa79b3

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

June 23, 2018

Package DI Number

10884521105669

Quantity per Package

400

Contains DI Package

20884521105666

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE