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3.0T 16ch HEAD NECK SPINE (HNS) ARRAY
EUDAMEDFDA UDIClass I (EU MDR)
Ref 5341333Model 1.5T and 3.0T Head Neck Spine (HNS) Arrays
Identity
- Trade Name
- 3.0T 16ch HEAD NECK SPINE (HNS) ARRAY EUDAMEDNA FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- 1.5T and 3.0T Head Neck Spine (HNS) Arrays EUDAMED3.0T 16 Channel Head Neck Spine HNS Coil FDA UDI
- Model / Reference
- 1.5T and 3.0T Head Neck Spine (HNS) Arrays EUDAMED5341333 EUDAMED3.0T 16CH HEAD NECK SPINE HNS ARRAY FDA UDI
- Description
- 3.0T 16 Channel Head Neck Spine HNS Coil FDA UDI
Identifiers
- Catalog Number
- 5341333 FDA UDI
- Primary DI / UDI-DI
- 00840682114264 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00365HP EUDAMED
- 510(k) Number
- K093348 FDA UDI
- FDA Product Code
- MOS FDA UDI
- EMDN Code
- Z1105018001 MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS EUDAMED
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Our 3.0T 16ch HEAD NECK SPINE (HNS) ARRAY is a high-performance medical device used in neurosurgery and interventional radiology to provide precise navigation and imaging capabilities.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8406821BUG00365HP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Coils
- EUDAMED SRN
- US-MF-000001664
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (2)
- EUDAMED cbb12d71-0a86-461d-891a-b954334ab3b8 61 fields · synced Jun 30, 2026
- FDA UDI 2384d889-d548-4165-9c40-83b7df92311e 35 fields · synced May 30, 2026