Catalog Number

VS0120.20A

Brand Name

20ga Curved Laser Probe - Alcon Compatible

Version/Model Number

VS0120.20A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K021696,K021696

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

2e099c84-3936-4991-9f71-04e1f92b7e97

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

B384VS012020A5

Quantity per Package

10

Contains DI Package

B384VS012020A1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box