Catalog Number

101095-SF IC

Brand Name

MegaBeam

Version/Model Number

101095-SF IC

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

K113709

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

59153d95-193d-48e9-b8dd-c4a5ed4bc515

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

November 30, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-