Identity
- Trade Name
- Bore Gauge TruSystem 7500 EU FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Model / Reference
- 02 FDA UDI
Identifiers
- Catalog Number
- 117897 FDA UDI
- Primary DI / UDI-DI
- 04251269204586 FDA UDI
- 510(k) Number
- K133506 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
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
Bore Gauge TruSystem 7500 EU 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
K133506 also covers:
- 5 Pin Bolt Wrench (Ball Handle) — NORAS MRI products GmbH
- 5 Pin Bolt Wrench small — NORAS MRI products GmbH
- 5 Pin Bolt Wrench small — NORAS MRI products GmbH
- All-Purpose Arch — NORAS MRI products GmbH
- All-Purpose Arch Adapter — NORAS MRI products GmbH
- All-Purpose Arch Set — NORAS MRI products GmbH
- All-Purpose Arch Set — NORAS MRI products GmbH
- Base Plate — NORAS MRI products GmbH
- Base Plate — NORAS MRI products GmbH
- Bore Gauge Alpha Maquet Plus EU — NORAS MRI products GmbH
- Bore Gauge Magnus US — NORAS MRI products GmbH
- Bore Gauge Magnus US — 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 3bce858d-fed9-4b6f-87e0-323596f03fd4 35 fields · synced Jun 8, 2026