Catalog Number

-

Brand Name

Talymed 10 cm x 10 cm

Version/Model Number

400-19

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

794f02c8-a550-4986-8934-5653fb3aa6e6

Public Version Date

January 05, 2021

Public Version Number

2

DI Record Publish Date

August 31, 2020

Package DI Number

10389142000190

Quantity per Package

5

Contains DI Package

00389142000193

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box