Catalog Number

-

Brand Name

FCI directional LASER PROBE 23G NIDEK

Version/Model Number

S9.1314.23

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

-

Product Code

HQB

Product Code Name

Photocoagulator And Accessories

Public Device Record Key

78dab130-7f1b-4077-b4c1-2f96606a466f

Public Version Date

June 07, 2021

Public Version Number

1

DI Record Publish Date

May 30, 2021

Package DI Number

23700773723397

Quantity per Package

10

Contains DI Package

13700773723390

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-