Catalog Number

-

Brand Name

Venus Velocity kit

Version/Model Number

PK000105

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

K162765

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

3bb1e579-288b-45ef-a640-7f9297c9ec9f

Public Version Date

May 24, 2021

Public Version Number

4

DI Record Publish Date

March 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-