Catalog Number

-

Brand Name

Single use Surgical Optical Fiber

Version/Model Number

FSI550

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

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

012eb7a9-9c26-480d-aa7a-2cf0957e04e4

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

May 12, 2022

Package DI Number

08059173392667

Quantity per Package

5

Contains DI Package

08059173392452

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton box