Identity
- Trade Name
- Cabel C1 Bottom Array 3T PH FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Model / Reference
- 01 FDA UDI
Identifiers
- Catalog Number
- 112108 FDA UDI
- Primary DI / UDI-DI
- 04251269204999 FDA UDI
- 510(k) Number
- K093693 FDA UDI
- FDA Product Code
- MOS FDA UDI
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 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
MR Safe FDA UDI
Category: MRI system coil, radio-frequency
Cabel C1 Bottom Array 3T PH 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
K093693 also covers:
- Cabel C1 Bottom Array 1.5T PH — NORAS MRI products GmbH
- Cabel C1 Top Array 1.5T PH — NORAS MRI products GmbH
- Cabel C1 Top Array 3T PH — NORAS MRI products GmbH
- Cabel C2 Top Array 1.5T PH — NORAS MRI products GmbH
- Cabel C2 Top Array 3T PH — NORAS MRI products GmbH
- Cabel C3 Bottom Array 1.5T PH — NORAS MRI products GmbH
- Cabel C3 Bottom Array 3T PH — NORAS MRI products GmbH
- Cabel C3 Top Array 1.5T PH — NORAS MRI products GmbH
- Cabel C3 Top Array 3T PH — NORAS MRI products GmbH
- NORAS OR HEAD COIL Bottom Array Philips 1.5T — NORAS MRI products GmbH
- NORAS OR HEAD COIL Bottom Array Philips 1.5T Refurbished — NORAS MRI products GmbH
- NORAS OR HEAD COIL Bottom Array Philips 1.5T Refurbished — 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 3e012da0-6b90-4e1e-b396-63932b08c86b 35 fields · synced May 31, 2026