Catalog Number

TM-206

Brand Name

TYTEK TRAUMA BANDAGE

Version/Model Number

TM-206

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)

-

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

93eb0cd7-08c5-4da4-8029-e8d56b804938

Public Version Date

February 21, 2022

Public Version Number

3

DI Record Publish Date

October 03, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-