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MR Safety Pad

FDA UDI

Class I (US FDA UDI)

by Pearl Technology AG

Identity

Trade Name
MR Safety Pad FDA UDI
Generic Name
Radiological general body-part positioner FDA UDI
Device Name
Positioning aid to prevent direct gantry contact in MRI FDA UDI
Model / Reference
ProFoam MR Safety Angel Pad FDA UDI
Description
Positioning aid to prevent direct gantry contact in MRI FDA UDI

Identifiers

Catalog Number
1301 FDA UDI
Primary DI / UDI-DI
07640178062160 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Radiological general body-part positioner

MR Safety Pad by Pearl Technology AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological general body-part positioner.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pearl Technology AG

Sources (1)

  • FDA UDI 7ae1b5bc-9a27-4301-a04c-f03e44911bae 34 fields · synced May 30, 2026