IntraX Film Processor I/MAC2016F

GUDID 05060209580777

MEDIVANCE INSTRUMENTS LIMITED

Dental automated x-ray film processor
Primary Device ID05060209580777
NIH Device Record Keyc54e450a-6147-4c80-95ee-7e11ce987759
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntraX Film Processor
Version Model NumberMK6
Catalog NumberI/MAC2016F
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
GS105060209580777 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IXWProcessor, Radiographic-Film, Automatic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

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
05060209580777 - IntraX Film Processor2022-08-15
05060209580777 - IntraX Film Processor2022-08-15
05060209580814 - ExtraXtender Film Processor2022-08-15

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