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 1.5T 16CH TT FULL SET consists of one patient support assembly, one fiducial marker block assembly, one box of 10 sterilized biopsy grids, 4Ch left and right coil elements, one 8Ch medial coil element, one 16Ch interface box, 1Ch left and right coil elements, and one medial plug. FDA UDI
Model / Reference: 989603217571 FDA UDI
Description: VS BREAST 1.5T 16CH TT FULL SET consists of one patient support assembly, one fiducial marker block assembly, one box of 10 sterilized biopsy grids, 4Ch left and right coil elements, one 8Ch medial coil element, one 16Ch interface box, 1Ch left and right coil elements, and one medial plug. FDA UDI

Identifiers

Primary DI / UDI-DI: 00884838119895 FDA UDI
510(k) Number: K112112 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

Yes

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

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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Cleared under the same submission

K112112 also covers:

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 1eca7b9e-5577-4d83-ac56-ce31dac48de3 35 fields · synced Sep 18, 2026