Catalog Number

HST01

Brand Name

Harmonic

Version/Model Number

HST01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 18, 2022

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

LRP

Product Code Name

TRAY, SURGICAL

Public Device Record Key

60aecb04-fc36-423d-b5cf-e5d83e91f63f

Public Version Date

March 21, 2022

Public Version Number

6

DI Record Publish Date

July 15, 2016

Package DI Number

30705036012621

Quantity per Package

4

Contains DI Package

20705036012624

Package Discontinue Date

March 18, 2022

Package Status

Not in Commercial Distribution

Package Type

CASE