Catalog Number

HRD002

Brand Name

HEMIGARD Interlock

Version/Model Number

HRD002

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MKY

Product Code Name

System, Skin Closure

Public Device Record Key

4d6e2c75-bd4b-4e0e-95b9-9ccd72e95b55

Public Version Date

October 11, 2022

Public Version Number

1

DI Record Publish Date

October 03, 2022

Package DI Number

10860007834223

Quantity per Package

12

Contains DI Package

00860007834226

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box