Identity
- Trade Name
- 31P/1H Head Coil FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- 31P/1H Head Coil FDA UDI
- Model / Reference
- 02015 FDA UDI
- Description
- 31P/1H Head Coil FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260487680829 FDA UDI
- 510(k) Number
- K213480 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
No
FDA UDI
Category: MRI system coil, radio-frequency
31P/1H Head Coil by RAPID Biomedical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K213480 also covers:
- 13C/1H Head Coil — RAPID Biomedical GmbH
- 13C/1H Head Coil — RAPID Biomedical GmbH
- 13C/1H Head Coil — RAPID Biomedical GmbH
- 23Na/1H Head Coil — RAPID Biomedical GmbH
- 23Na/1H Head Coil — RAPID Biomedical GmbH
- 23Na/1H Head Coil — RAPID Biomedical GmbH
- 23Na/1H Head Coil — RAPID Biomedical GmbH
- 31P/1H Head Coil — RAPID Biomedical GmbH
- 31P/1H Head Coil — RAPID Biomedical 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
- RAPID Biomedical GmbH
Sources (1)
- FDA UDI 80454e74-042b-4647-a138-ec1481b1d022 35 fields · synced May 30, 2026