IntraX Film Processor I/MAC2016F

GUDID 05060209580777

MEDIVANCE INSTRUMENTS LIMITED

Dental automated x-ray film processor

• Primary Device ID: 05060209580777
• NIH Device Record Key: c54e450a-6147-4c80-95ee-7e11ce987759
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IntraX Film Processor
• Version Model Number: MK6
• Catalog Number: I/MAC2016F
• 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	05060209580777 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093503

FDA Product Code

• IXW: Processor, Radiographic-Film, Automatic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-15
• Device Publish Date: 2022-08-06

Devices Manufactured by MEDIVANCE INSTRUMENTS LIMITED

• 05060209580012 - Velopex AquaCut Fluid Abrasion Unit: 2022-08-15
• 05060209580777 - IntraX Film Processor: 2022-08-15
• 05060209580777 - IntraX Film Processor: 2022-08-15
• 05060209580814 - ExtraXtender Film Processor: 2022-08-15