Dunlee Sentinelle

GUDID 00884838119925

VS BRST 1.5T 16CH TT FULSET w SHALOW RSR consists of one patient support assembly, one fiducial marker block assembly, one box of 10 sterilized biopsy grids, 4Ch left and right lateral coil elements, one 8Ch medial coil element, one 16Ch interface box, 1Ch left and right coil elements, and one medial plug.

Philips Medical Systems Nederland B.V.

MRI system coil, radio-frequency

• Primary Device ID: 00884838119925
• NIH Device Record Key: d295b434-8c7f-400d-a548-846d1a1aefbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dunlee Sentinelle
• Version Model Number: 989603217301
• Company DUNS: 413819707
• Company Name: Philips Medical Systems Nederland B.V.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
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• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838119925 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112112

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-08
• Device Publish Date: 2023-04-28

On-Brand Devices [Dunlee Sentinelle]

• 00884838109070: Lateral Array Coil Right VT
• 00884838109056: Single Loop Coil Right VT
• 00884838109049: Single Loop Coil Left VT
• 00884838109032: Medial Plug VT
• 00884838109025: Medial Array Coil VT
• 00884838109018: Interface Box VT
• 00884838109001: Lateral Array Coil Right VT
• 00884838108998: Lateral Array Coil Left VT
• 00884838102132: Lateral Array Coil Left VT
• 00884838109407: Medial Single Loop Coil Right VG STR
• 00884838109391: Medial Single Loop Coil Left VG STR
• 00884838109384: Medial Array Coil VG STR
• 00884838109377: Cable Tray HYP VG STR
• 00884838109360: Lateral Array Coil Right VG STR
• 00884838109353: Lateral Array Coil Left VG STR
• 00884838109346: Lateral Single Loop Coil Right VG GE750
• 00884838109339: Lateral Single Loop Coil Left VG GE750
• 00884838109322: Medial Plug VG GE750
• 00884838109315: Medial Array Coil VG GE750
• 00884838109308: Interface Box VG GE750
• 00884838109292: Lateral Array Coil Right VG GE750
• 00884838109285: Lateral Array Coil Left VG GE750
• 00884838109278: Lateral Single Loop Coil Right VG GE450
• 00884838109261: Lateral Single Loop Coil Left VG GE450
• 00884838109254: Medial Plug VG GE450
• 00884838109247: Medial Array Coil VG GE450
• 00884838109230: Cable Tray VG GE450
• 00884838109223: Lateral Array Coil Right VG GE450
• 00884838109216: Lateral Array Coil Left VG GE450
• 00884838109209: Lateral Single Loop Coil Right VGTT
• 00884838109193: Lateral Single Loop Coil Left VGTT
• 00884838109186: Medial Plug VGTT
• 00884838109179: Medial Array Coil VGTT
• 00884838109162: Interface Box VGTT 8Ch
• 00884838109155: Lateral Array Coil Right VGTT
• 00884838109148: Lateral Array Coil Left VGTT
• 00884838109131: Single Loop Coil Right VT
• 00884838109124: Single Loop Coil Left VT
• 00884838109117: Medial Plug VT
• 00884838109100: Medial Array Coil VT
• 00884838109094: Interface Box VT
• 00884838109087: Interface Box VT
• 00884838109452: Lateral Array Coil Right VS 8Ch
• 00884838109445: Lateral Array Coil Left VS 8Ch
• 00884838109438: Lateral Single Loop Coil Right VG STR
• 00884838109421: Lateral Single Loop Coil Left VG STR
• 00884838109872: 8Ch Medial Coil Sen 3T
• 00884838109865: 16Ch Interface Box Breast Coil Sen 3T
• 00884838109858: 4Ch Right Lateral Coil Sen 3T
• 00884838109841: 4Ch Left Lateral Coil Sen 3T