Catalog Number

-

Brand Name

SPECTRALIS, HRT3, HEP

Version/Model Number

HEYEX 2 SW V2.2

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

-

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

HPT

Product Code Name

Perimeter, Automatic, Ac-Powered

Public Device Record Key

dff9d58c-fe00-4267-b141-e8e25c17aaf3

Public Version Date

April 08, 2022

Public Version Number

5

DI Record Publish Date

December 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-