Dunlee Sentinelle

FDA UDI

Class II (US FDA UDI)

by Philips Medical Systems Nederland B.V.

Identity

Trade Name: Dunlee Sentinelle FDA UDI
Generic Name: MRI system coil, radio-frequency FDA UDI
Device Name: VT3T 8Ch TT Titan Full Set w Grid contains: 1 Vanguard Atlas/Titan; BOX of 10 BIOPSY GRID, STERILIZED; 1 COIL INTERFACE BOX VT 3T; 1 COIL 8CH MEDIAL ARRAY VT 3T; 1 COIL LAT 8CH ARRAY LEFT VT 3T; 1 COIL LAT 8CH ARRAY RIGHT VT 3T; 1 COIL SINGLE LOOP LEFT VT 3T 8CH; 1 COIL SINGLE LOOP RIGHT VT 3T 8CH; 1 COIL MEDIAL PLUG VT 3T FDA UDI
Model / Reference: 989603218331 FDA UDI
Description: VT3T 8Ch TT Titan Full Set w Grid contains: 1 Vanguard Atlas/Titan; BOX of 10 BIOPSY GRID, STERILIZED; 1 COIL INTERFACE BOX VT 3T; 1 COIL 8CH MEDIAL ARRAY VT 3T; 1 COIL LAT 8CH ARRAY LEFT VT 3T; 1 COIL LAT 8CH ARRAY RIGHT VT 3T; 1 COIL SINGLE LOOP LEFT VT 3T 8CH; 1 COIL SINGLE LOOP RIGHT VT 3T 8CH; 1 COIL MEDIAL PLUG VT 3T FDA UDI

Identifiers

Primary DI / UDI-DI: 00884838120082 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe 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 1a86d30a-2c4c-4c3b-9b4b-740a356615b0 34 fields · synced Sep 18, 2026