Catalog Number

-

Brand Name

Reusable Surgical Optical Fiber

Version/Model Number

OAF002713

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

9862ad50-047f-493f-9354-953649015560

Public Version Date

October 24, 2022

Public Version Number

7

DI Record Publish Date

August 29, 2016

Package DI Number

08033945933920

Quantity per Package

5

Contains DI Package

08033945933456

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton