Identity
- Trade Name
- Grid Needle Block reusable ATEC raw FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Model / Reference
- 01 FDA UDI
Identifiers
- Catalog Number
- MR10055 FDA UDI
- Primary DI / UDI-DI
- 04251269202100 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
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Category: MRI system coil, radio-frequency
Grid Needle Block reusable ATEC raw 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
K010570 also covers:
- Blockmarker for Mammotome — NORAS MRI products GmbH
- Breast Biopsie Set Disposable — 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 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 291edba1-c711-4634-b737-5bf96e976158 35 fields · synced May 30, 2026