ProBelt 140 MRI P Extension

FDA UDI

Class I (US FDA UDI)

by Pearl Technology AG

Identity

Trade Name: ProBelt 140 MRI P Extension FDA UDI
Generic Name: Radiological general body-part positioner FDA UDI
Device Name: Universal patient positioning belt for MR and CT imaging. FDA UDI
Model / Reference: ProBelt 140 MRI P Extension FDA UDI
Description: Universal patient positioning belt for MR and CT imaging. FDA UDI

Identifiers

Catalog Number: 1240 FDA UDI
Primary DI / UDI-DI: 07640178061415 FDA UDI
FDA Product Code: KXH FDA UDI
GMDN Term: Radiological general body-part positioner FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 892.1830 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Radiological general body-part positioner

ProBelt 140 MRI P Extension by Pearl Technology AG — 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: Pearl Technology AG

Sources (1)

FDA UDI f2b5da10-3626-47a2-838e-9b1c2cac09fe 35 fields · synced May 30, 2026