Catalog Number

-

Brand Name

25GA Curved Illuminating Laser Probe

Version/Model Number

7625.ALCU

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

K132614,K132614

Product Code

HQB

Product Code Name

PHOTOCOAGULATOR AND ACCESSORIES

Public Device Record Key

69f8b3c8-31a3-4183-9650-1af9d9cd0954

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2016

Package DI Number

10632307002172

Quantity per Package

6

Contains DI Package

00632307002175

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box