FDA.reportPublic FDA data

Endorectal Coil Support

Primary DI
04260487680423
Brand
Endorectal Coil Support
Company
RAPID Biomedical GmbH
Model
ZUB-01955
Catalog number
M7006CY
Device description
ER Coil Support
Published
2020-03-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MOSCoil, Magnetic Resonance, Specialty

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191539000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1915390001.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil SupportRapid Biomedical GmbH2020-01-31MOS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260487680423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260487680423042604876804234260487680423

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 Pressure70 KiloPascal107 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius24 Degrees Celsius
Handling Environment Temperature59 Degrees Fahrenheit75.2 Degrees Fahrenheit
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-13 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316037741
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
042604876802321.5T Endorectal CoilO-HLE-015-01899M7006CL2020-03-09
042604876802493.0T Endorectal CoilO-HLE-030-01900M7006CM2020-03-09
042604876804161.5T Endorectal CoilO-HLE-015-01946M7006CQ2020-03-09
04260487680430Endorectal Coil Screws Repair KitZUB-01978none2020-03-09
04260487680447Endorectal Coil Holder Repair KitZUB-01979none2020-03-09
0426048768057731P/1H Head Coil020002023-02-13
0426048768058423Na/1H Head Coil020012023-02-13
0426048768059113C/1H Head Coil020022023-02-13
0426048768060731P/1H Head Coil020032023-02-13
0426048768061423Na/1H Head Coil020042023-02-13
0426048768062113C/1H Head Coil020052023-02-13
0426048768063831P/1H Head Coil020062023-02-13
0426048768064523Na/1H Head Coil020072023-02-13
0426048768065213C/1H Head Coil020082023-02-13
0426048768069031P/1H Head Coil021042023-02-13
0426048768070613C/1H Head Coil021052023-02-13
0426048768078223Na/1H Head Coil020182023-02-13
0426048768079931P/1H Head Coil020122023-02-13
0426048768080523Na/1H Head Coil020132023-02-13
0426048768081213C/1H Head Coil020142023-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278925282NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDMOS2026-05-11
04260486610339NBAC 3.0T PH I FlexLMT Medical Systems GmbHMOS2026-04-28
04260486610605NBAC 1.5T GE P SpineLMT Medical Systems GmbHMOS2026-04-28
00814848020836Contour Hand Wrist 0.55TQUALITY ELECTRODYNAMICS LLCMOS2026-04-23
00850083516000Nuzzle Body Array, 1.5TInkspace Imaging, Inc.MOS2026-04-21
00850083516017Silhouette Body Array – PH 3T (Cherry Blossoms)Inkspace Imaging, Inc.MOS2026-04-21
00860008041371Snuggle Pediatric Array – PH 3T (Dino)Inkspace Imaging, Inc.MOS2026-04-21
00860008041395Nuzzle Body Array – PH 3T (Whimsical)Inkspace Imaging, Inc.MOS2026-04-21
00884838130548DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130555DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130562DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130579DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130586DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130593DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130609DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
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00884838130623DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838132597DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838132603DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
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00884838108073MRI CoilsPhilips Ds North America LLCMOS2025-10-01
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00884838119000MR CoilsPhilips Medical Systems Nederland B.V.MOS2025-10-01
00884838108080MRI CoilsPhilips Ds North America LLCMOS2025-09-30
00884838111172DUNLEEPhilips Medical Systems Nederland B.V.MOS2025-09-30