Catalog Number

-

Brand Name

25ga Stiff Illuminated MultiFlex™ Inverted Laser Probe, Iridex Connector

Version/Model Number

V6352-25AR

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

Yes

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

K121187,K121187

Product Code

HQB

Product Code Name

Photocoagulator And Accessories

Public Device Record Key

835af58a-06b5-4bb6-aac0-daca59f2c9db

Public Version Date

April 11, 2019

Public Version Number

1

DI Record Publish Date

April 03, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-