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Alpine Stirrups
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref RT-5100-54LModel Patient Transport
by Qfix
Identity
- Trade Name
- Alpine Stirrups FDA UDI
- Generic Name
- Heel stirrup FDA UDI
- Device Name
- Stirrup, Left FDA UDI
- Model / Reference
- RT-5100-54L EUDAMEDFDA UDIPatient Transport EUDAMED
- Description
- Stirrup, Left FDA UDI
Identifiers
- Catalog Number
- RT-5100-54L FDA UDI
- Primary DI / UDI-DI
- 00841962119467 EUDAMEDFDA UDI
- Basic UDI-DI
- 8419621PTTRANSPORTT7 EUDAMED
- 510(k) Number
- K230312 FDA UDI
- FDA Product Code
- IZI FDA UDIJAK FDA UDIKPS FDA UDILNH FDA UDIOUO FDA UDIOWB FDA UDI
- EMDN Code
- Z11039080 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Heel stirrup FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1600 FDA UDI892.1750 FDA UDI892.1200 FDA UDI892.1000 FDA UDI892.1650 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Heel stirrup
Alpine Stirrups by Qfix — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Heel stirrup.
- UMF Medical — UNITED METAL FABRICATORS, INC. · Class I
- SchureMed — SCHUERCH CORPORATION · Class I
- STIRRUP HOLDERS — BIRD & CRONIN, LLC · Class I
- SchureMed — SCHUERCH CORPORATION · Class I
- SchureMed — SCHUERCH CORPORATION · Class I
- David Scott Company — David Scott Company. · Class I
- SchureMed — SCHUERCH CORPORATION · Class I
- UMF Medical — UNITED METAL FABRICATORS, INC. · Class I
Cleared under the same submission
K230312 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Qfix
Sources (2)
- FDA UDI ab0052c8-7368-465b-ae79-a464bee519e5 36 fields · synced Jul 11, 2026
- EUDAMED 274f6fec-35d0-4c9b-b794-0e61f5733394 61 fields · synced Jul 11, 2026