Catalog Number

-

Brand Name

Venus Versa - SR515 light block package

Version/Model Number

PK000325

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K153717

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

06b01bea-ab43-4713-b1fb-91c1be4f2865

Public Version Date

December 19, 2018

Public Version Number

1

DI Record Publish Date

November 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-