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Edge Guide System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref RT-5100-55Model Patient Transport
by Qfix
Identity
- Trade Name
- Edge Guide System FDA UDI
- Generic Name
- Patient transfer sliding board FDA UDI
- Device Name
- Lithotomy Edge Guide System FDA UDI
- Model / Reference
- RT-5100-55 EUDAMEDFDA UDIPatient Transport EUDAMED
- Description
- Lithotomy Edge Guide System FDA UDI
Identifiers
- Catalog Number
- RT-5100-55 FDA UDI
- Primary DI / UDI-DI
- 00841962120340 EUDAMEDFDA UDI
- Basic UDI-DI
- 8419621PTTRANSPORTT7 EUDAMED
- 510(k) Number
- K160627 FDA UDI
- FDA Product Code
- FRZ FDA UDIIYE FDA UDIJAI FDA UDIJAK FDA UDIKPS FDA UDILHN FDA UDILNH FDA UDIOUO FDA UDI
- EMDN Code
- V080504 PATIENT TRANSFER BOARDS AND TABLES EUDAMED
- GMDN Term
- Patient transfer sliding board FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6775 FDA UDI892.5050 FDA UDI892.5770 FDA UDI892.1750 FDA UDI892.1200 FDA UDI892.1000 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Patient transfer sliding board
Edge Guide System by Qfix — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Patient transfer sliding board.
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Cleared under the same submission
K160627 also covers:
- AirDrive Trolley™ — Qfix
- AirShuttle Locating Bar — Qfix
- AirShuttle Locating Bar — Qfix
- AirShuttle Transfer Handle — Qfix
- AirShuttle Transfer Handle — Qfix
- Applicator Clamp Holder — Qfix
- Applicator Clamp Holder — Qfix
- InfinityLock™ — Qfix
- Leg Extension — Qfix
- Leg Extension — Qfix
- Leg Extension — Qfix
- Symphony™ — Qfix
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 befb761e-ae73-4da1-8035-7508a64e33ec 36 fields · synced Aug 2, 2026
- EUDAMED c827f219-d103-458f-9f2a-925e64f19524 61 fields · synced Aug 2, 2026