Identity
- Trade Name
- Dunlee Sentinelle FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- VS BRST 1.5T 8CH TT FUL SET w ESPREE RSR consists of one patient support assembly, one medial coil element, one interface box, 1Ch left and right coil elements, one medial plug, 3Ch left and right coil elements, one fiducial marker block assembly, and one box of 10 sterilized biopsy grids. FDA UDI
- Model / Reference
- 989603217331 FDA UDI
- Description
- VS BRST 1.5T 8CH TT FUL SET w ESPREE RSR consists of one patient support assembly, one medial coil element, one interface box, 1Ch left and right coil elements, one medial plug, 3Ch left and right coil elements, one fiducial marker block assembly, and one box of 10 sterilized biopsy grids. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838120051 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
Dunlee 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 898ca57c-eec2-4132-adf3-117641e582a9 33 fields · synced Sep 18, 2026