Catalog Number

1005

Brand Name

HemCon® Patch PRO, 2in x 2in

Version/Model Number

1

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"

Yes

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

K080818,K080818,K080818

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

e542f65d-2fef-4273-be25-664a1c7990bb

Public Version Date

March 10, 2021

Public Version Number

2

DI Record Publish Date

October 14, 2020

Package DI Number

20870053001859

Quantity per Package

10

Contains DI Package

00870053001855

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box