Catalog Number

-

Brand Name

FCI directional LASER PROBE / EXTENDABLE 25G IRIDEX/B&L

Version/Model Number

S9.1321.25

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

3db9a7fa-7ef3-45ec-948f-f963dc09ccae

Public Version Date

June 07, 2021

Public Version Number

1

DI Record Publish Date

May 30, 2021

Package DI Number

23700773723441

Quantity per Package

10

Contains DI Package

13700773723444

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-