Catalog Number

101045

Brand Name

MegaBeam® Fiber Optic Delivery System with Additional Tips and Handpiece

Version/Model Number

MegaBeam® Single Use Bare Fiber 400um, Flat Tip, ID (1x1h)

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

1c2296ff-eaa7-4ac5-a75a-66f8f2691ff7

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

March 07, 2017

Package DI Number

04049089300508

Quantity per Package

2

Contains DI Package

04049089200501

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box