Catalog Number

HK105

Brand Name

Harmonic

Version/Model Number

HK105

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2016

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

LFL

Product Code Name

Instrument, ultrasonic surgical

Public Device Record Key

b04fe9b2-01fa-4dea-b239-366dfc860235

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 15, 2016

Package DI Number

30705036002127

Quantity per Package

180

Contains DI Package

20705036002120

Package Discontinue Date

September 30, 2016

Package Status

Not in Commercial Distribution

Package Type

CASE