Catalog Number

413115

Brand Name

Zetuvit Plus Silicone 8x8cm P10

Version/Model Number

413114

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)

Yes

Over the Counter (OTC)

-

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

15ceda43-8130-4232-bde6-c197f6c5de0b

Public Version Date

June 22, 2021

Public Version Number

2

DI Record Publish Date

August 03, 2020

Package DI Number

04052199503660

Quantity per Package

10

Contains DI Package

04052199515038

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-