Catalog Number

-

Brand Name

HEP

Version/Model Number

HEP with HEYEX 2 SW V3.2c

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2020

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HOO

Product Code Name

Perimeter, Ac-Powered

Public Device Record Key

19f9b789-f65b-4e7f-891d-a308dc1134cb

Public Version Date

March 13, 2020

Public Version Number

2

DI Record Publish Date

July 11, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-