IntraX Film Processor

FDA UDI

Class II (US FDA UDI)

by Medivance Instruments Limited

Identity

Trade Name: IntraX Film Processor FDA UDI
Generic Name: Dental automated x-ray film processor FDA UDI
Model / Reference: MK6 FDA UDI

Identifiers

Catalog Number: I/MAC2016F FDA UDI
Primary DI / UDI-DI: 05060209580777 FDA UDI
510(k) Number: K093503 FDA UDI
FDA Product Code: IXW FDA UDI
GMDN Term: Dental automated x-ray film processor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1900 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental automated x-ray film processor

IntraX Film Processor by Medivance Instruments Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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ExtraXtender Film Processor — MEDIVANCE INSTRUMENTS LIMITED · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medivance Instruments Limited

Sources (1)

FDA UDI c54e450a-6147-4c80-95ee-7e11ce987759 34 fields · synced Jun 7, 2026