Philips Sentinelle

GUDID 00884838119277

dS 1.5T Interface Box

Philips Medical Systems Nederland B.V.

MRI system coil, radio-frequency

Primary Device ID	00884838119277
NIH Device Record Key	6450ac84-1f5d-4281-b515-776316104d6d
Commercial Distribution Status	In Commercial Distribution
Brand Name	Philips Sentinelle
Version Model Number	459801716342
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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838119277 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K213735

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