Identity
- Trade Name
- OP Kopfhalter LUCY Upgrade Set Siemens FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- The NORAS OR Head Holder LUCY is used for intra-operative imaging in the X-ray or CT environment. Together with the NORAS OR head coils 1.5T/3T the head holder LUCY is used for intra-operative MR imaging during neurosurgery on the open skull. FDA UDI
- Model / Reference
- 01 FDA UDI
- Description
- The NORAS OR Head Holder LUCY is used for intra-operative imaging in the X-ray or CT environment. Together with the NORAS OR head coils 1.5T/3T the head holder LUCY is used for intra-operative MR imaging during neurosurgery on the open skull. FDA UDI
Identifiers
- Catalog Number
- 120338 FDA UDI
- Primary DI / UDI-DI
- 04251269205996 FDA UDI
- 510(k) Number
- K211658 FDA UDI
- FDA Product Code
- HBL FDA UDI
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4460 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: MRI system coil, radio-frequency
OP Kopfhalter LUCY Upgrade Set Siemens by NORAS MRI products GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K211658 also covers:
- All-Purpose Arch Adapter - LUCY — NORAS MRI products GmbH
- All-Purpose Arch LUCY — NORAS MRI products GmbH
- All-Purpose Arch Set LUCY — NORAS MRI products GmbH
- Base Plate LUCY Maquet — NORAS MRI products GmbH
- Base Plate LUCY long — NORAS MRI products GmbH
- Base Plate Set Getinge A0, Getinge B0, Mizuho — NORAS MRI products GmbH
- Base Plate Set Trumpf — NORAS MRI products GmbH
- Bore Gauge LUCY — NORAS MRI products GmbH
- Bottom Coil Retainer LUCY — NORAS MRI products GmbH
- Brainlab Adapter - LUCY — NORAS MRI products GmbH
- Central Nut LUCY — NORAS MRI products GmbH
- Clamp LUCY — NORAS MRI products GmbH
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 II | Pending data |
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Manufacturer
- Manufacturer
- NORAS MRI products GmbH
Sources (1)
- FDA UDI 889a35bd-ee6f-43b1-bdb6-14b3f28e8aa3 36 fields · synced May 30, 2026