Catalog Number

1485CH

Brand Name

Prevahex

Version/Model Number

1485CH

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K140389

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

15f1f16b-ef3b-45e4-828a-10560a07da03

Public Version Date

December 24, 2019

Public Version Number

1

DI Record Publish Date

December 16, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-