Catalog Number

101145

Brand Name

MegaBeam® Reusable Fiber Optic Delivery System

Version/Model Number

MegaBeam® Reusable Bare Fiber 365um, Flat Tip, noID

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

b2ab3a7d-0490-4851-83d8-06695468a7c0

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

January 31, 2017

Package DI Number

04049089300409

Quantity per Package

2

Contains DI Package

04049089200402

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box