Identity
- Trade Name
- Breast Biopsy Kit FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Model / Reference
- 01 FDA UDI
Identifiers
- Catalog Number
- 111460 FDA UDI
- Primary DI / UDI-DI
- 04251269200182 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: MRI system coil, radio-frequency
Breast Biopsy Kit by NORAS MRI products GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as MRI system coil, radio-frequency.
- Dunlee Sentinelle — Philips Medical Systems Nederland B.V. · Class II
- 16Ch Flex SPEEDER Pad Kit — NEOCOIL, LLC · Class II
- ScanMed Long Bone (L) Coil — SCANMED, LLC · Class II
- ScanMed Elbow Coil — SCANMED, LLC · Class II
- Invivo — Philips DS North America LLC · Class II
- TMJ COIL — Esaote S.p.A. · Class I
- dS Flex Coil M 1.5T — Philips Healthcare (Suzhou) Co., Ltd. · Class IIb
- Atlas SPEEDER Head-Neck Coil — QUALITY ELECTRODYNAMICS LLC · Class II
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 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
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 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
- Cranio-caudal fixation unit CC-320-PLUS — 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 d68c4b9a-36ad-4b20-874c-fde01738c19b 35 fields · synced May 30, 2026