Identity
- Trade Name
- Symphony™ FDA UDI
- Generic Name
- Patient transfer sliding board FDA UDI
- Device Name
- Alta AirShuttle Upgrade FDA UDI
- Model / Reference
- RT-5100-48 FDA UDI
- Description
- Alta AirShuttle Upgrade FDA UDI
Identifiers
- Catalog Number
- RT-5100-48 FDA UDI
- Primary DI / UDI-DI
- 00841962119481 FDA UDI
- 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
- GMDN Term
- Patient transfer sliding board FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6775 FDA UDI892.5050 FDA UDI892.5770 FDA UDI892.1750 FDA UDI892.1200 FDA UDI892.1000 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Symphony™ by Qfix — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Edge Guide System — Qfix
- InfinityLock™ — Qfix
- Leg Extension — Qfix
- Leg Extension — Qfix
- Leg Extension — Qfix
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- FDA UDI 17a0f0bc-f9a9-4bfa-8e4a-96e74138cd22 36 fields · synced Jun 1, 2026