Catalog Number

-

Brand Name

23ga Flex Tapered Illum Laser Probe, Iridex Connector/Short 19ga; Box of 10

Version/Model Number

V6315-23AV

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

8447142a-4fe5-4666-9dc5-1ba1f03fa8a3

Public Version Date

May 07, 2019

Public Version Number

4

DI Record Publish Date

March 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-