FDA.reportPublic FDA data

Alpine Stirrups, Metric, Left

Primary DI
00841962120548
Brand
Alpine Stirrups, Metric, Left
Company
Qfix
Model
RT-5100-54L-CE
Catalog number
RT-5100-54L-CE
Device description
Alpine Stirrups, Metric, Left
Published
2026-04-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IZISystem, X-Ray, Angiographic
JAKSystem, X-Ray, Tomography, Computed
KPSSystem, Tomography, Computed, Emission
LNHSystem, Nuclear Magnetic Resonance Imaging
OUOTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
OWBInterventional Fluoroscopic X-Ray System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZISystem, X-Ray, AngiographicRadiology2
JAKSystem, X-Ray, Tomography, ComputedRadiology2
KPSSystem, Tomography, Computed, EmissionRadiology2
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2
OUOTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic ResonanceRadiology2
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230312000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230312000Iris AirShuttle™Qfix2023-03-31IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841962120548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841962120548008419621205488419621205480841962120548

GMDN Terms#

Term, Definition table
TermDefinition
Heel stirrupA device used during a medical/surgical procedure to steadily hold a patient's foot (feet) by cradling the heel. It is typically attached to an operating table, examination table, or treatment chair and is considered an accessory to these devices. This device is typically constructed of metal and plastic and used in pairs mainly for patients in lithotomic position for obstetrical, urological, colonic, or rectal procedures. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1 712-737-8688regulatory@cqmedical.com

Regulatory Flags#

DUNS number
808875397
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841439115305MultiFix 2RT-5411RT-54112026-06-04
00841439115312MultiFix 2 - JointGlowRT-5412RT-54122026-06-04
00841439115329Extremity RiserRT-5413RT-54132026-06-04
00841439115336Extremity Riser - JointGlowRT-5414RT-54142026-06-04
00841439115343MultiFix Indexing PostRT-5415RT-54152026-06-04
00841962120500Single Hand Extremity FibreplastRT-E778KPR2HRT-E778KPR2H2026-06-05
00841962120517Knee / Elbow Extremity FibreplastRT-E778KPR2NERT-E778KPR2NE2026-06-05
00841962120524Foot Extremity FibreplastRT-E778KPR3FTRT-E778KPR3FT2026-06-05
00841962120531Dual Hand / Shoulder Extremity FibreplastRT-E778KPR3HSRT-E778KPR3HS2026-06-05
00841439115237Opti-TattUTRT-4100UTRT-41002026-05-29
00841439115244Opti-TattUTRT-4200UTRT-42002026-05-29
00841439115251Opti-TattUTRT-4300UTRT-43002026-05-29
00841962120562FibreplastRT-A182KYSDNRT-A182KYSDN2026-05-26
00841962120425Opti Handle Thermoplastic AdapterRT-4546-05RT-4546-052026-05-18
00841962120319Aquaplast PS™PS-1309CSSPS-1309CSS2025-07-09
10841962107447Aquaplast PS™PS-1307PS-13072016-09-13
10841962108307VacQfix™RT-4517-4079VF15RT-4517-4079VF152016-09-13
10841962109090QUANTUM™ CT OverlayRT-4550TE24RT-4550TE242016-09-13
10841962109274kVue™ EdgeRT-4551KVERT-4551KVE2016-09-13
10841962109403Stradivarius™RT-4558CB01RT-4558CB012016-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
00850025268424Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-05-12
B133NEUROQ412601160NeuroQSYNTERMED INCORPORATEDKPS2026-03-04
00850025268400Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-02-27
B133ECTB422512090Cardiac ToolboxSYNTERMED INCORPORATEDKPS2026-02-26
00850025268394Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-01-21
00850025268387Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-11-03
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B133NEUROQ412507140NeuroQSYNTERMED INCORPORATEDKPS2025-08-06
B133ECTB4225063000Emory Cardiac ToolboxSYNTERMED INCORPORATEDKPS2025-08-01
00850025268349Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-07-11
B133NEUROQ402505160NeuroQSYNTERMED INCORPORATEDKPS2025-06-18
00850025268363Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-06-03
00850025268356Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-23
00850025268332Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-16
08800025300299AVIEWCORELINE SOFT CO.,LTD.JAK2025-03-27
B133ECTB422503240Emory Cardiac ToolboxSYNTERMED INCORPORATEDKPS2025-03-26
08800025300367AVIEW CACCORELINE SOFT CO.,LTD.JAK2025-03-24
00850025268318Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-03-21
B133NEUROQ402503120NeuroQSYNTERMED INCORPORATEDKPS2025-03-21
B133NEUROQ40241250NeuroQSYNTERMED INCORPORATEDKPS2025-01-27
00850025268325Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-11-21
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