FDA.reportPublic FDA data

DUNLEE SENTINELLE

Primary DI
00884838115149
Brand
DUNLEE SENTINELLE
Company
Philips Medical Systems Nederland B.V.
Model
300009412081
Device description
Medial Single Loop Coil Right VG STR
Published
2022-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MOSCoil, Magnetic Resonance, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOSCoil, Magnetic Resonance, SpecialtyRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838115149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838115149008848381151498848381151490884838115149

GMDN Terms#

Term, Definition table
TermDefinition
MRI system coil, radio-frequencyA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-30 Degrees Celsius65 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)722-9377XX@XX.XX

Regulatory Flags#

DUNS number
413819707
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838123748Spectral CT VeridaSpectral CT Verida7283452026-05-26
00884838126398Spectral CT Verida RTSpectral CT Verida RT7283572026-05-26
00884838127555Upgrade Spectral CT VeridaUpgrade Spectral CT Verida7283562026-05-26
00884838127562Upgrade Spectral CT Verida RTUpgrade Spectral CT Verida RT7283722026-05-26
00884838127876Upgrade Spectral CT 7500 SW5.4Upgrade Spectral CT 7500 SW5.47283752026-05-26
00884838127883Upgrades Spectral CT 7500 RT SW5.4Upgrades Spectral CT 7500 RT SW5.47283552026-05-26
00884838074798IntelliSpace PACS Anywhere1.4.x8375082026-02-07
00884838104402IngeniaUpgrade to MR 77007821302026-01-27
00884838128415Ingenia BlueSeal SE7821932026-01-07
00884838128422Ingenia BlueSeal XE7821922026-01-07
00884838128439Ingenia MR 77007821992026-01-07
00884838128446Ingenia MR 5300 7821962026-01-07
00884838128453Ingenia Ingenia Elition S7821972026-01-07
00884838128460Ingenia Ingenia Elition X7821982026-01-07
00884838128477Ingenia, MR5300, MR7700, AchievaIngenia Ambition S7821942026-01-07
00884838128484Ingenia 3.0TIngenia Ambition X7821952026-01-07
00884838128514IngeniaEvolution Upgrade 3.0T 7822022026-01-07
00884838128521Ingenia ElitionSmartPath to Ingenia Elition X7822042026-01-07
00884838128552IngeniaEvolution Upgrade 1.5T 7822012026-01-07
00884838128569MR 7700Upgrade to MR 7700 7822062026-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04068151995251MAGNETOM LuminaSiemens Healthineers AGMOS2026-02-23
04068151995305MAGNETOM SolaSiemens Healthineers AGMOS2026-02-23
04068151995343MAGNETOM VidaSiemens Healthineers AGMOS2026-02-23
04068151995367MAGNETOM Vida FitSiemens Healthineers AGMOS2026-02-23
04068151995374MAGNETOM Viato.MobileSiemens Healthineers AGMOS2026-02-23
00860008041364Snuggle Pediatric Array, 1.5TInkspace Imaging, Inc.MOS2026-01-22
00860008041388Silhouette Body Array, 1.5TInkspace Imaging, Inc.MOS2026-01-22
00850042098165Template Holder with FiducialsPromaxo, Inc.MOS2026-01-21
04068151020472BIOGRAPH OneSiemens Healthineers AGMOS2026-01-20
04056869299556MAGNETOM Flow.NeoSiemens Healthcare GmbHMOS2026-01-19
04068151036732MAGNETOM Flow.EliteSiemens Healthcare GmbHMOS2026-01-19
04068151047950MAGNETOM Flow.EliteSiemens Healthcare GmbHMOS2026-01-19
00884838089624PhilipsPhilips Ds North America LLCMOS2025-12-23
00884838089631PhilipsPhilips Ds North America LLCMOS2025-12-23
00884838117952PhilipsPhilips Ds North America LLCMOS2025-12-23
00884838118300MR CoilsPhilips Medical Systems Nederland B.V.MOS2025-12-23
00884838118317MR CoilsPhilips Medical Systems Nederland B.V.MOS2025-12-23
00884838118409MR CoilsPhilips Medical Systems Nederland B.V.MOS2025-12-23
00884838118430MR CoilsPhilips Medical Systems Nederland B.V.MOS2025-12-23
00884838123045DUNLEEPhilips Medical Systems Nederland B.V.MOS2025-12-23
00850045949075XENOVIEW 3.0T Chest Coil-GE PremierPolarean, Inc.MOS2025-12-19
001989530019981.5T AIR Posterior ArrayUSA INSTRUMENTS, INC.MOS2025-12-10
00850043319184Swoop Transmit and Receive Radio Frequency Head CoilHyperfine Operations, Inc.MOS2025-12-04
008500289325371.5T 16ch Breast CoilNEOCOIL, LLCMOS2025-11-18
00850045949044XENOVIEW 3.0T Chest CoilPolarean, Inc.MOS2025-09-23
00850045949051XENOVIEW 3.0T Chest CoilPolarean, Inc.MOS2025-09-23
008666130003528Tx32Rx 7T Head CoilNova Medical, IncMOS2025-07-16
04056869996202MAGNETOM Flow.AceSiemens Shenzhen Magnetic Resonance Ltd.MOS2025-07-07
0081484802081216ch Flex SPEEDER Medium 1.5TQUALITY ELECTRODYNAMICS LLCMOS2025-05-20
0081484802082916ch Flex SPEEDER Large 1.5TQUALITY ELECTRODYNAMICS LLCMOS2025-05-20