BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

DUNLEE SENTINELLE

DI: 00884838109490 · Model: 1Ch Left Coil Element Sen 1.5T · Philips Medical Systems Nederland B.V.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: DUNLEE SENTINELLE
Primary DI: 00884838109490
Version / Model: 1Ch Left Coil Element Sen 1.5T
Catalog Number: 300006546891
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: 2022-04-01
Public Version: 3
Public Version Date: 2025-09-25
Public Version Status: Update
Public Device Record Key: 06528009-3075-485a-b190-83123a959d0c

Device Description

Single Loop Coil Left VS

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
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
MOS	Coil, Magnetic Resonance, Specialty	Radiology	892.1000	2

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	00884838109490	GS1

Customer Contacts

Phone: +1(800)722-9377
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K112112	000

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: -30 – 65 Degrees Celsius
Type: Storage Environment Humidity
Temperature Range: 10 – 95 Percent (%) Relative Humidity
Type: Storage Environment Atmospheric Pressure
Temperature Range: 50 – 106 KiloPascal