Identity
- Trade Name
- Breast BI 7 MR Coil Set 3T FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Model / Reference
- 05 FDA UDI
Identifiers
- Catalog Number
- 118890 FDA UDI
- Primary DI / UDI-DI
- 04251269205590 FDA UDI
- 510(k) Number
- K162651 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
Breast BI 7 MR Coil Set 3T by NORAS MRI products GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as MRI system coil, radio-frequency.
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Cleared under the same submission
K162651 also covers:
- Adapter frame 70cm Breast BI 7 — NORAS MRI products GmbH
- Breast BI 7 Frame UI Set — NORAS MRI products GmbH
- Breast BI 7 MR Coil 1.5T — NORAS MRI products GmbH
- Breast BI 7 MR Coil 3T — NORAS MRI products GmbH
- Breast BI 7 MR Coil 3T — NORAS MRI products GmbH
- Breast BI 7 MR Coil 3T — NORAS MRI products GmbH
- Breast BI 7 MR Coil 3T — NORAS MRI products GmbH
- Breast BI 7 MR Coil 3T — NORAS MRI products GmbH
- Breast BI 7 MR Coil Set 1.5T — NORAS MRI products GmbH
- Breast BI 7 MR Coil Set 3T — NORAS MRI products GmbH
- Breast BI 7 MR Coil Set 3T — NORAS MRI products GmbH
- Breast BI 7 MR Coil Set 3T — 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 07ef2381-1ae6-4888-ad11-a1202aaf565a 34 fields · synced May 30, 2026