Catalog Number

-

Brand Name

HydroTac transp. comfort 8x8cm st P10

Version/Model Number

685925

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)

-

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

3bb3c7b8-5e04-44e6-96cf-9875ae9d4744

Public Version Date

June 22, 2021

Public Version Number

2

DI Record Publish Date

September 01, 2020

Package DI Number

04052199273587

Quantity per Package

8

Contains DI Package

04052199273570

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-