Velopex AquaCut Fluid Abrasion Unit I/MAC8502F /I/MAC8503F /I/MAC8508F

GUDID 05060209580012

MEDIVANCE INSTRUMENTS LIMITED

Dental abrasive air jet system Dental abrasive air jet system Dental abrasive air jet system Dental abrasive air jet system Dental abrasive air jet system Dental abrasive air jet system Dental abrasive air jet system Dental abrasive air jet system Dental abrasive air jet system

Primary Device ID	05060209580012
NIH Device Record Key	6bd055c7-4244-42de-946e-40e0772122b0
Commercial Distribution Status	In Commercial Distribution
Brand Name	Velopex AquaCut Fluid Abrasion Unit
Version Model Number	MK5
Catalog Number	I/MAC8502F /I/MAC8503F /I/MAC8508F
Company DUNS	228066353
Company Name	MEDIVANCE INSTRUMENTS LIMITED
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	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060209580012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K024105

FDA Product Code

KOJ

Airbrush