FDA.reportPublic FDA data

Flex Coils Knee Stabilizer

Primary DI
00856181003602
Brand
Flex Coils Knee Stabilizer
Company
NEOCOIL, LLC
Model
60
Device description
These accessory immobilization devices are intended for use in conjunction with a NeoCoil Flex Coil for patient comfort and stabilization. Please refer to the device labeling for intended use of your particular NeoCoil Flex Coil.
Published
2017-03-16
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
K113474000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1134740001.5T GEM FLEX COILNeocoil, LLC2012-03-16MOS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856181003602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856181003602008561810036028561810036020856181003602

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
781155176
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008500289325371.5T 16ch Breast Coil53NC1492292025-11-18
0085002893249032ch AIR Open Coil Suite, 3.0T49NC1390202023-01-27
0085002893250632ch AIR Open Coil Suite, 1.5T50NC1390212023-01-27
008561810039301.5T 16ch Shoulder Coil (System)93NC1430012020-09-09
008561810039233.0T 16ch Shoulder Coil (System)92NC1430002020-07-17
008561810038931.5T 16Ch Breast Coil89M7006PH2019-06-10
008561810038243.0T 16ch Breast Coil82M7006PA2018-04-26
008500289324523T 16ch Breast Coil45NC1492092023-03-23
008500289324691.5T 16ch Breast Coil46NC1492292023-03-23
00850028932513Biopsy Grid Assembly, Pack, Breast Coil51NC1494442023-03-23
00850028932520Drape Pack, Biopsy, Breast Coil52NC1494752023-03-23
008500289322543.0T AIR Open Head Neck Posterior 9ch25NC1392002023-01-27
008500289322613.0T AIR Open Neck Chest Anterior 7ch26NC1392012023-01-27
008500289322783.0T AIR Open Head Anterior 16ch27NC1392022023-01-27
008500289322851.5T AIR Open Head Neck Posterior 9ch28NC1392032023-01-27
008500289322921.5T AIR Open Neck Chest Anterior 7ch29NC1392042023-01-27
008500289323081.5T AIR Open Head Anterior 16ch30NC1392052023-01-27
00856181003312ECG CT Gating Device312017-03-21
00856181003329ECG CT Gating Receiver322017-03-21
00856181003336ECG CT Gating Cable332017-03-21

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
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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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00884838098190MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838098367MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838098510MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838108073MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838118997MR CoilsPhilips Medical Systems Nederland B.V.MOS2025-10-01
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