FDA.reportPublic FDA data

Alpine Stirrups

Primary DI
00841962119467
Brand
Alpine Stirrups
Company
Qfix
Model
RT-5100-54L
Catalog number
RT-5100-54L
Device description
Stirrup, Left
Published
2025-07-09
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
00841962119467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841962119467008419621194678419621194670841962119467

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-842-8688regulatory@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-54112026-06-04
00841439115312MultiFix 2 - JointGlowRT-54122026-06-04
00841439115329Extremity RiserRT-54132026-06-04
00841439115336Extremity Riser - JointGlowRT-54142026-06-04
00841439115343MultiFix Indexing PostRT-54152026-06-04
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
10841962109441kVue™ Stradivarius™RT-4558KV1RT-4558KV12016-09-13
10841962108000SofTouch™RT-4464-1RT-4464-12016-09-13
10841962108130VacQfix™RT-4517100130PENF45MRT-4517100130PENF45M2016-09-13
10841962108147VacQfix™RT-4517-100150F70RT-4517-100150F702016-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
00860015781918iCAC DeviceBunkerhill Health Inc.JAK2026-05-31
04573596201367OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201398OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201404OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201411OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201435OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596202159OASISFUJIFILM CORPORATIONLNH2026-05-29
10884521785977superDimensionCovidien LPJAK2026-05-29
10884521851184superDimensionCovidien LPJAK2026-05-29
05060508110057Cydar MapsCYDAR LIMITEDOWB2026-05-27
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
10810068810858MONARCH™ ControllerAuris Health, Inc.JAK2026-05-27
08055186671225A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671232A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671249A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671256A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08809365283033SG HealthcareSG Healthcare Co., Ltd.OWB2026-04-24
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.LNH2026-04-23
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.LNH2026-04-22
08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162885Mask DSPS®-PROSCL set/5MACROMEDICS B.V.LNH2026-04-22
08720168163356DSPS-Prominent® SH profile set/2MACROMEDICS B.V.LNH2026-04-22
08720168163387DSPS PRO Mask Shim Set HNSMACROMEDICS B.V.LNH2026-04-22