Identity
- Trade Name
- Breast Biopsie Set Disposable FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Model / Reference
- 02 FDA UDI
Identifiers
- Catalog Number
- 118943 FDA UDI
- Primary DI / UDI-DI
- 04251269203206 FDA UDI
- 510(k) Number
- K010570 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: MRI system coil, radio-frequency
Breast Biopsie Set Disposable 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
K010570 also covers:
- Blockmarker for Mammotome — NORAS MRI products GmbH
- Breast Biopsy Set — NORAS MRI products GmbH
- Breast Biopsy Set Grid Reusable — NORAS MRI products GmbH
- Coaxial Highfield 12G 111mm 3T, unsteril — NORAS MRI products GmbH
- Cranio-Caudal Fixation Unit CC-320-Plus — NORAS MRI products GmbH
- Grid Biopsy Unit: lateral for GE 8-Channel Breastc — NORAS MRI products GmbH
- Grid Needle Block reusable ATEC raw — NORAS MRI products GmbH
- Grid Needle Block reusable Encor 10G 4-hole — NORAS MRI products GmbH
- Grid Needle Block reusable Encor 10G 5-hole — NORAS MRI products GmbH
- Grid Needle Block reusable Mammotome — NORAS MRI products GmbH
- Grid biopsy unit for BBC — NORAS MRI products GmbH
- Grid biopsy unit: medial, for GE 8-Channel breast — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- NORAS MRI products GmbH
Sources (1)
- FDA UDI 9dba0130-2ed5-4029-9121-4b4786f1b900 35 fields · synced Jun 1, 2026