Catalog Number

HARSB

Brand Name

HARMONIC OSTEOVUE

Version/Model Number

HARSB

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

K141122,K141122,K141122

Product Code

LFL

Product Code Name

Instrument, ultrasonic surgical

Public Device Record Key

0bd6a6b1-0a84-4486-b928-cb3cf3432655

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 24, 2016

Package DI Number

30705036014571

Quantity per Package

36

Contains DI Package

20705036014574

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE