Duns Number:506069240
Catalog Number
AP-400-30
Brand Name
MegaBeam® Fiber Optic Delivery System with Additional Tips and Handpiece
Version/Model Number
MegaBeam® Single Use Handpiece 400um, 30 deg, 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
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
3b51931b-5b64-4ddc-bc0e-678c55562985
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
March 07, 2017
Package DI Number
04049089300614
Quantity per Package
5
Contains DI Package
04049089200617
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 39 |