Philips Sentinelle

GUDID 00884838119406

dS 3.0T 1CH Lateral Right

Philips Medical Systems Nederland B.V.

MRI system coil, radio-frequency

• Primary Device ID: 00884838119406
• NIH Device Record Key: b7e5b4c5-4067-4ba8-b0c4-0ffd4315881d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Philips Sentinelle
• Version Model Number: 459801716332
• 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: false
• 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
• 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
• Phone: 1-800-722-9377
• Email: xx@xx.xx
• Phone: 1-800-722-9377
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1100 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838119406 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213727

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: 2024-12-25
• Device Publish Date: 2024-12-17

On-Brand Devices [Philips Sentinelle]

• 00884838120228: Sentinelle, Biopsy Grid
• 00884838119468: DS SENTINELLE BRST COIL, BIOPSY KIT 3.0T Contains - dS 3.0T 1CH Lateral Left, dS 3.0T 1CH Latera
• 00884838119451: DS SENTINELLE BRST COIL, BIOPSY KIT 1.5T Contains - dS 1.5T 1CH Lateral Left, dS 1.5T 1CH Latera
• 00884838119420: dS 3.0T Medial Plug
• 00884838119413: dS 1.5T Medial Plug
• 00884838119406: dS 3.0T 1CH Lateral Right
• 00884838119390: dS 1.5T 1CH Lateral Right
• 00884838119383: dS 3.0T 1CH Lateral Left
• 00884838119376: dS 1.5T 1CH Lateral Left
• 00884838119369: dS Headrest
• 00884838119352: dS Patient Support
• 00884838119345: dS 3.0T 4CH Lateral Right
• 00884838119338: dS 1.5T 4CH Lateral Right
• 00884838119321: dS 3.0T 4CH Lateral Left
• 00884838119314: dS 1.5T 4CH Lateral Left
• 00884838119307: dS 3.0T 8CH Medial
• 00884838119291: dS 1.5T 8CH Medial
• 00884838119284: dS 3.0T Interface Box
• 00884838119277: dS 1.5T Interface Box