Identity
- Trade Name
- Dunelee Sentinelle FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- VT 3T 8CH TT TITAN FULL SET w GRID contains one box of 10 Biopsy grids, one Interface box, one Medial array, one Lateral array left and right, one Single loop left and right, one Medial plug and one Patient support FDA UDI
- Model / Reference
- 989603216941 FDA UDI
- Description
- VT 3T 8CH TT TITAN FULL SET w GRID contains one box of 10 Biopsy grids, one Interface box, one Medial array, one Lateral array left and right, one Single loop left and right, one Medial plug and one Patient support FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838119857 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: MRI system coil, radio-frequency
Dunelee Sentinelle by Philips Medical Systems Nederland B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Philips Medical Systems Nederland B.V.
Sources (1)
- FDA UDI 04dda276-c1bd-4bd4-aecf-98b7f6cab29d 35 fields · synced Oct 6, 2026