Catalog Number

VS0120.27I

Brand Name

27ga Curved Laser Probe - Iridex Compatible

Version/Model Number

VS0120.27I

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

7229cd06-1f05-41b5-873d-b1b83a203dbd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

B384012027I5

Quantity per Package

10

Contains DI Package

B384VS012027I1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box