Catalog Number

HP054

Brand Name

Harmonic

Version/Model Number

HP054

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

-

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

c1402c1d-3dd0-4c30-ac9a-cf061dca8f20

Public Version Date

April 02, 2021

Public Version Number

4

DI Record Publish Date

July 15, 2016

Package DI Number

30705036002141

Quantity per Package

27

Contains DI Package

20705036002144

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE