Catalog Number

HSA08

Brand Name

Harmonic

Version/Model Number

HSA08

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

39e2c72b-6c39-433f-b669-fd9cbaf9ac30

Public Version Date

October 16, 2019

Public Version Number

3

DI Record Publish Date

July 15, 2016

Package DI Number

30705036011938

Quantity per Package

126

Contains DI Package

10705036011934

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE