FireCam HD Intraoral Camera

FDA UDI

Class I (US FDA UDI)

by DIGIRAY Corp.

Identity

Trade Name: FireCam HD Intraoral Camera FDA UDI
Generic Name: Surgical video camera FDA UDI
Device Name: The advanced camera & optics technology of the FireCam HD IntraOral Camera enables you to produce high-quality digital images for diagnosing the patients in your facility. The reader can be used as a central reader, which distributes images throughout your facility, or as an exam-room based solution. The reader is DICOM 3.0 compatible with existing systems and uses a full range of low-cost. The design features a 360° touch-switch for capture operation. FDA UDI
Model / Reference: FR61 FDA UDI
Description: The advanced camera & optics technology of the FireCam HD IntraOral Camera enables you to produce high-quality digital images for diagnosing the patients in your facility. The reader can be used as a central reader, which distributes images throughout your facility, or as an exam-room based solution. The reader is DICOM 3.0 compatible with existing systems and uses a full range of low-cost. The design features a 360° touch-switch for capture operation. FDA UDI

Identifiers

Primary DI / UDI-DI: 08809466040610 FDA UDI
FDA Product Code: EAX FDA UDI
GMDN Term: Surgical video camera FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

Yes

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Expiration Date

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Manufacturing Date

Yes

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Dimensions & Sizes

Size: Height — 2.3 Centimeter FDA UDI
Length — 23 Centimeter FDA UDI
Width — 1.8 Centimeter FDA UDI
Weight — 120 Gram FDA UDI

Category: Surgical video camera

FireCam HD Intraoral Camera by DIGIRAY Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: DIGIRAY Corp.

Sources (1)

FDA UDI 5e0eaaf6-1430-4f76-90e6-e7345ff9a825 35 fields · synced May 30, 2026