Philips Sentinelle

Basic Information

• Brand Name: Philips Sentinelle
• Primary DI: 00884838119451
• Version / Model: 989603216542
• Company Name: Philips Medical Systems Nederland B.V.
• Labeler DUNS: 413819707
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-17
• Public Version: 1
• Public Version Date: 2024-12-25
• Public Version Status: New
• Public Device Record Key: e8fa9525-0b81-4643-9848-8ef6d5f9be51

Device Description

DS SENTINELLE BRST COIL, BIOPSY KIT 1.5T Contains - dS 1.5T 1CH Lateral Left, dS 1.5T 1CH Lateral Right, dS 1.5T Medial Plug, Sentinelle, Biopsy Grid and Fiducial Marker Grid Block Assembly.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PXP	Breast Biopsy / Localization Tray	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40749	MRI system coil, radio-frequency	A radio-frequency (RF) coil acts as a transmitter, receiver, or both a transmitter and receiver of RF pulses necessary for diagnostic magnetic resonance imaging (MRI) procedures. It is used to enhance image resolution by improving signal to noise characteristics. There are two main kinds of RF coils: volume coils (which surround the part of the body being imaged) and surface coils (which are placed and secured directly on or under an area of interest). This group of devices includes a variety RF coil designs and configurations including, e.g., surface coils, phased array coils, paired saddle coils, Hemholtz pair coils or bird cage coils.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838119451	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

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