Catalog Number

T71616

Brand Name

exsalt T7 Wound Dressings

Version/Model Number

09-0116

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K113564,K113564,K113564

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

b4af2608-29f0-41ab-9842-9605485b2eca

Public Version Date

October 05, 2022

Public Version Number

2

DI Record Publish Date

September 23, 2020

Package DI Number

07540127000116

Quantity per Package

5

Contains DI Package

07540127000109

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box