Catalog Number

-

Brand Name

Single use Surgical Optical Fiber

Version/Model Number

OAF006091

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

e0d62e10-4166-4c87-8732-742269201e7f

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

April 06, 2022

Package DI Number

08033945939069

Quantity per Package

5

Contains DI Package

08033945939052

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton box