Identity
- Trade Name
- Grid biopsy unit: lateral, medial, cc FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Model / Reference
- 01 FDA UDI
Identifiers
- Catalog Number
- 111252 FDA UDI
- Primary DI / UDI-DI
- 04251269201899 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
No
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
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Category: MRI system coil, radio-frequency
Grid biopsy unit: lateral, medial, cc 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
- 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
K082373 also covers:
- 4 CH BI Breast MR Coil Kit 3T — 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-NO 3T — 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 Fixation Rail Set Wide — 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 Coil fixiation Rail/TIM 4G spare part (n. s) — 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 fdf04262-d2ab-4dae-9f4a-94949ee45321 35 fields · synced Jun 1, 2026