Catalog Number

-

Brand Name

HEMOCELL

Version/Model Number

2×2cm

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

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

-

Product Code

MGQ

Product Code Name

Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Public Device Record Key

60ffb042-86d3-4f8c-8fb6-4ce4efe46cfc

Public Version Date

April 01, 2021

Public Version Number

1

DI Record Publish Date

March 24, 2021

Package DI Number

26940610101767

Quantity per Package

20

Contains DI Package

16940610101760

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box