Horseshoe Headrest

FDA UDIEUDAMED

Class I (US FDA UDI)

by IMRIS Imaging, Inc.

Identity

Trade Name: Horseshoe Headrest FDA UDI
Generic Name: Freestanding headrest, reusable FDA UDI
Device Name: Horseshoe Headrest Starter Kit, HFD 200 FDA UDI
Model / Reference: 116961-000 FDA UDI
Description: Horseshoe Headrest Starter Kit, HFD 200 FDA UDI

Identifiers

Primary DI / UDI-DI: 00857534006844 FDA UDI
FDA Product Code: HBM FDA UDI
GMDN Term: Freestanding headrest, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 882.4440 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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Freestanding headrest, reusable

Horseshoe Headrest by IMRIS Imaging, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: IMRIS Imaging, Inc.

Sources (2)

FDA UDI 87681cf2-d7e1-4c1b-826d-325f801582a3 33 fields · synced Jun 17, 2026
EUDAMED 1 fields · synced Jun 2, 2026