Catalog Number

1012

Brand Name

HemCon GuardaCare® PRO, 2in x 2in, 8ply

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

K092357,K092357,K092357

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

6673271b-92c8-4fdb-a998-e5ad9ae4db63

Public Version Date

March 10, 2021

Public Version Number

2

DI Record Publish Date

December 10, 2020

Package DI Number

20870053001354

Quantity per Package

10

Contains DI Package

00870053001350

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box