Catalog Number

1491BOX

Brand Name

Prevahex

Version/Model Number

1491BOX

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,K140389,K140389

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

a273fc31-e530-4acd-87c4-a1d79b453ac7

Public Version Date

March 11, 2021

Public Version Number

2

DI Record Publish Date

February 26, 2021

Package DI Number

B5591491CASE3

Quantity per Package

4

Contains DI Package

B5591491BOX1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE