Identity
- Trade Name
- pearltec FDA UDI
- Generic Name
- Radiological headrest FDA UDI
- Device Name
- Patient positioning aid for MR and CT imaging. FDA UDI
- Model / Reference
- ProFoam Head Support FDA UDI
- Description
- Patient positioning aid for MR and CT imaging. FDA UDI
Identifiers
- Catalog Number
- 1279 FDA UDI
- Primary DI / UDI-DI
- 07640178061811 FDA UDI
- FDA Product Code
- IWY FDA UDI
- GMDN Term
- Radiological headrest FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1920 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
MR Safe FDA UDI
Category: Radiological headrest
pearltec by Pearl Technology AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiological headrest.
- Positioning Cushion — Medtec LLC · Class II
- Headrest — Medtec LLC · Class II
- Neck & Brachial Plexus SatPad™ Set — Sat Pad Inc. · Class II
- Headrest — Medtec LLC · Class II
- Nurofit Premiere™ — Qfix · Class I
- Neuro Head Holder — Qfix · Class I
- SCANCOAT — DOMICO MED-DEVICE, LLC · Class I
- SCANCOAT — DOMICO MED-DEVICE, LLC · Class II
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 d2902670-8448-42fe-b326-58d324dee907 34 fields · synced Jun 1, 2026