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: VS BREAST 3T 8CH TT FULL SET w PACKAGING contains 1 INTERFACE BOX, COIL MEDIAL ARRAY, MEDIAL PLUG, SINGLE LOOP RIGHT & LEFT, LATERAL ARRAY LEFT & RIGHT, PATIENT SUPPORT, AND A BOX OF 10 STERILIZED BIOPSY GRIDS FDA UDI
Model / Reference: 989603217831 FDA UDI
Description: VS BREAST 3T 8CH TT FULL SET w PACKAGING contains 1 INTERFACE BOX, COIL MEDIAL ARRAY, MEDIAL PLUG, SINGLE LOOP RIGHT & LEFT, LATERAL ARRAY LEFT & RIGHT, PATIENT SUPPORT, AND A BOX OF 10 STERILIZED BIOPSY GRIDS FDA UDI

Identifiers

Primary DI / UDI-DI: 00884838119956 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 d009a038-8eb3-4d7d-9cbc-36204b15ed73 34 fields · synced Sep 18, 2026