CyberWand Probe Set

GUDID 00855279005009

CYBERSONICS INC

Ultrasonic lithotripsy system handpiece Ultrasonic lithotripsy system handpiece Ultrasonic lithotripsy system handpiece Ultrasonic lithotripsy system handpiece Ultrasonic lithotripsy system handpiece Ultrasonic lithotripsy system handpiece Ultrasonic lithotripsy system handpiece Ultrasonic lithotripsy system handpiece Ultrasonic lithotripsy system handpiece Ultrasonic lithotripsy system handpiece Ultrasonic lithotripsy system handpiece Ultrasonic lithotripsy system handpiece Ultrasonic lithotripsy system handpiece Ultrasonic lithotripsy system handpiece Ultrasonic lithotripsy system handpiece

Primary Device ID	00855279005009
NIH Device Record Key	6bc2e668-f4a9-4c9a-b2cd-3d237741cc1c
Commercial Distribution Status	In Commercial Distribution
Brand Name	CyberWand Probe Set
Version Model Number	CW-RBP
Company DUNS	943561522
Company Name	CYBERSONICS INC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855279005009 [Primary]
GS1	10855279005006 [Package] Package: [3 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K120303

FDA Product Code

FFK	Lithotriptor, Electro-Hydraulic

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-08-31

On-Brand Devices [CyberWand Probe Set]

00855279005009	CW-RBP
H891CWRBPBX3	CW-RBP