ExtraXtender Film Processor

Basic Information

• Brand Name: ExtraXtender Film Processor
• Primary DI: 05060209580814
• Version / Model: MK6
• Catalog Number: I/MAC1017F
• Company Name: MEDIVANCE INSTRUMENTS LIMITED
• Labeler DUNS: 228066353
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-06
• Public Version: 1
• Public Version Date: 2022-08-15
• Public Version Status: New
• Public Device Record Key: d30b532b-5a3e-4350-90e1-987c25d3c40d

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IXW	Processor, Radiographic-Film, Automatic	Radiology	892.1900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15939	Dental automated x-ray film processor	A mains electricity (AC-powered) automated dental x-ray film processor designed to be used in the dental practise for the rapid processing of films. This x-ray film processing system will automatically develop, fix, wash, and dry dental x-ray film. It is typically of floor or desktop design.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060209580814	GS1

Premarket Submissions

Submission Number	Supplement Number
K111167	000