Identity
- Trade Name
- Grid Needle Block disposable 16G FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Model / Reference
- 01 FDA UDI
Identifiers
- Catalog Number
- 112143 FDA UDI
- Primary DI / UDI-DI
- 04251269202056 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
Yes
FDA UDI
Single Use
Yes
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 Needle Block disposable 16G 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 637ca2b1-edc4-4491-8a5c-3125e731bd0e 35 fields · synced Jun 1, 2026