Catalog Number

RENOVIX-20x30

Brand Name

SALVIN RENOVIX

Version/Model Number

MCG 12 23 U

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 21, 2019

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)

Yes

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

NPL

Product Code Name

Barrier, Animal Source, Intraoral

Public Device Record Key

8bb47987-7d60-4348-8758-450d18b95278

Public Version Date

May 22, 2019

Public Version Number

3

DI Record Publish Date

February 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-