Catalog Number

HAR17F

Brand Name

Harmonic

Version/Model Number

HAR17F

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)

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

d83d960e-a981-4632-bfdd-b50796ec7854

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

June 16, 2017

Package DI Number

30705036014731

Quantity per Package

24

Contains DI Package

10705036014737

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE