Catalog Number

-

Brand Name

Puracyn® Plus Professional Formula

Version/Model Number

6549

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

-

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

K150799,K150799

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

9952df43-9b62-4182-a63f-962e4fbb3004

Public Version Date

October 27, 2022

Public Version Number

1

DI Record Publish Date

October 19, 2022

Package DI Number

10818582012789

Quantity per Package

6

Contains DI Package

00818582012782

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box