Catalog Number

-

Brand Name

27GA Curved Laser Probe - Iridex

Version/Model Number

PD727.22

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"

Yes

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

K122905,K122905

Product Code

HQB

Product Code Name

PHOTOCOAGULATOR AND ACCESSORIES

Public Device Record Key

cd3cb0ef-7889-4a55-8889-07d57dcc68b7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 06, 2016

Package DI Number

10632307000949

Quantity per Package

5

Contains DI Package

00632307000942

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box