Catalog Number

HAR1136

Brand Name

Harmonic

Version/Model Number

HAR1136

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

K200841,K200841

Product Code

LFL

Product Code Name

Instrument, ultrasonic surgical

Public Device Record Key

5ff6b70b-05a8-483d-8492-4ad35e932c2e

Public Version Date

April 25, 2022

Public Version Number

2

DI Record Publish Date

December 18, 2020

Package DI Number

20705036026164

Quantity per Package

6

Contains DI Package

10705036026167

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX