Catalog Number

101015

Brand Name

MegaBeam® Fiber Optic Delivery System with Additional Tips and Handpiece

Version/Model Number

MegaBeam® Single Use Bare Fiber 600um, Flat Tip PF, 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

fde0aa86-d8d1-4c70-84b0-77afb5ab9171

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

March 07, 2017

Package DI Number

04049089300478

Quantity per Package

2

Contains DI Package

04049089200471

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box