Catalog Number

-

Brand Name

Zetuvit Plus Silicone 12,5x12,5cm P10

Version/Model Number

Zetuvit Plus Silicone 12,5x12,5cm P10

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

NAC

Product Code Name

Dressing, Wound, Hydrophilic

Public Device Record Key

8cde9a4d-f849-4b33-be2b-efdeeca6b073

Public Version Date

June 22, 2021

Public Version Number

2

DI Record Publish Date

September 01, 2020

Package DI Number

04052199503707

Quantity per Package

10

Contains DI Package

04052199515045

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-