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

GUDID 05060209580012

MEDIVANCE INSTRUMENTS LIMITED

Dental abrasive air jet system
Primary Device ID05060209580012
NIH Device Record Key6bd055c7-4244-42de-946e-40e0772122b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameVelopex AquaCut Fluid Abrasion Unit
Version Model NumberMK5
Catalog NumberI/MAC8502F /I/MAC8503F /I/MAC8508F
Company DUNS228066353
Company NameMEDIVANCE INSTRUMENTS LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105060209580012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KOJAirbrush

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05060209580012]

Moist Heat or Steam Sterilization


[05060209580012]

Moist Heat or Steam Sterilization


[05060209580012]

Moist Heat or Steam Sterilization


[05060209580012]

Moist Heat or Steam Sterilization


[05060209580012]

Moist Heat or Steam Sterilization


[05060209580012]

Moist Heat or Steam Sterilization


[05060209580012]

Moist Heat or Steam Sterilization


[05060209580012]

Moist Heat or Steam Sterilization


[05060209580012]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-15
Device Publish Date2022-08-06

Devices Manufactured by MEDIVANCE INSTRUMENTS LIMITED

05060209580012 - Velopex AquaCut Fluid Abrasion Unit2022-08-15
05060209580012 - Velopex AquaCut Fluid Abrasion Unit2022-08-15
05060209580777 - IntraX Film Processor2022-08-15
05060209580814 - ExtraXtender Film Processor2022-08-15

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