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Headboard Assembly

FDA UDI

Class II (US FDA UDI)

by IMRIS Imaging, Inc.

Identity

Trade Name
Headboard Assembly FDA UDI
Generic Name
Basic diagnostic x-ray system table, powered FDA UDI
Device Name
ORT400 Headboard Assembly FDA UDI
Model / Reference
118714-000 FDA UDI
Description
ORT400 Headboard Assembly FDA UDI

Identifiers

Primary DI / UDI-DI
00857534006721 FDA UDI
FDA Product Code
KXJ FDA UDI
GDC FDA UDI
GMDN Term
Basic diagnostic x-ray system table, powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1980 FDA UDI
878.4960 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Basic diagnostic x-ray system table, poweredMRI system table, powered

Headboard Assembly by IMRIS Imaging, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as MRI system table, powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
IMRIS Imaging, Inc.

Sources (1)

  • FDA UDI fc52a47f-b2e1-43a9-8b01-cc5aec7eebb9 33 fields · synced May 30, 2026