Catalog Number

7539LF

Brand Name

Telfa

Version/Model Number

7539LF

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

KGX

Product Code Name

Tape and bandage, adhesive

Public Device Record Key

9ea50e1c-0b55-46e1-8a6a-be9aef926d5f

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 27, 2018

Package DI Number

20884527021922

Quantity per Package

50

Contains DI Package

10884527021925

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK