Catalog Number

-

Brand Name

Venus Versa

Version/Model Number

VE102407

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

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

cb38785a-6a59-4461-8c0b-6822c2c6380c

Public Version Date

November 21, 2018

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

07290016540499

Quantity per Package

1

Contains DI Package

07290016540383

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-