Catalog Number

-

Brand Name

Reusable Surgical Optical Fiber

Version/Model Number

FSV550

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

-

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

28e8c80f-2bd2-4d35-b4ef-d9608e5d9e03

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

May 13, 2022

Package DI Number

08059173392674

Quantity per Package

5

Contains DI Package

08059173392469

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton box