Identity
- Trade Name
- Base Unit fixation plate FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Model / Reference
- 02 FDA UDI
Identifiers
- Catalog Number
- 111242 FDA UDI
- Primary DI / UDI-DI
- 04251269205279 FDA UDI
- 510(k) Number
- K081118 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: MRI system coil, radio-frequency
Base Unit fixation plate 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
K081118 also covers:
- 4 CH BI Breast MR Coil Kit 1, 5 T — NORAS MRI products GmbH
- 4 CH BI Breast MR Coil Kit 1.5T — NORAS MRI products GmbH
- Base Plate — NORAS MRI products GmbH
- Base Unit fixation plate — NORAS MRI products GmbH
- Blocking Plate — NORAS MRI products GmbH
- Breast Biopsy 4-Ch Coil BI 320-PA-GE 1.5T — NORAS MRI products GmbH
- Breast Biopsy Kit — NORAS MRI products GmbH
- Breast Biopsy Kit — NORAS MRI products GmbH
- Breast Biopsy Patient Rest BI 320-PA-PH — NORAS MRI products GmbH
- Breast Coil fixiation Rail/TIM 4G — NORAS MRI products GmbH
- Breast Coil fixiation Rail/TIM 4G spare part — NORAS MRI products GmbH
- Breast Stabilisation Cushion — 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 a71cca0c-58ce-48a5-ad7a-b693b953e449 35 fields · synced May 30, 2026