DUNLEE SENTINELLE

GUDID 00884838127609

ADD-ON ACCESSORIES BREAST SEN MR SET contains - 2 Fiducial Marker Grid Block Assembly and 1 BREAST GRID (USER STERILIZED)

Philips Medical Systems Nederland B.V.

Needle guide, single-use

• Primary Device ID: 00884838127609
• NIH Device Record Key: 22d526d0-6a1f-4831-90e7-e079dbd92682
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUNLEE SENTINELLE
• Version Model Number: 989603217421
• Company DUNS: 413819707
• Company Name: Philips Medical Systems Nederland B.V.
• Device Count: 1
• DM Exempt: false
• 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
• Email: XX@XX.XX
• Phone: +1(800)722-9377
• Email: XX@XX.XX
• Phone: +1(800)722-9377
• Email: XX@XX.XX
• Phone: +1(800)722-9377
• Email: XX@XX.XX
• Phone: +1(800)722-9377
• Email: XX@XX.XX
• Phone: +1(800)722-9377
• Email: XX@XX.XX
• Phone: +1(800)722-9377
• Email: XX@XX.XX
• Phone: +1(800)722-9377
• Email: XX@XX.XX
• Phone: +1(800)722-9377
• Email: XX@XX.XX
• Phone: +1(800)722-9377
• Email: XX@XX.XX
• Phone: +1(800)722-9377
• Email: XX@XX.XX
• Phone: +1(800)722-9377
• Email: XX@XX.XX
• Phone: +1(800)722-9377
• Email: XX@XX.XX

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838127609 [Primary]

FDA Product Code

• PXP: Breast Biopsy / Localization Tray

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: 2025-01-20
• Device Publish Date: 2025-01-10

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