Catalog Number

H787VC1470PRO

Brand Name

VenaCure 1470 Pro

Version/Model Number

PDMS00252

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

K181632,K181632,K181632

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

a7860fca-9f76-4153-a244-e0f4e8b7e001

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

October 11, 2018

Package DI Number

08033945939038

Quantity per Package

1

Contains DI Package

08033945938925

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

trolley