Identity
- Trade Name
- VacQfix™ FDA UDI
- Generic Name
- Vacuum-mould patient positioning system FDA UDI
- Device Name
- VacQfix Cushion, 230cm x 120/80cm, 3 Chambers FDA UDI
- Model / Reference
- RT-4517-0003 FDA UDI
- Description
- VacQfix Cushion, 230cm x 120/80cm, 3 Chambers FDA UDI
Identifiers
- Catalog Number
- RT-4517-0003 FDA UDI
- Primary DI / UDI-DI
- 10841962108055 FDA UDI
- FDA Product Code
- JAI FDA UDI
- GMDN Term
- Vacuum-mould patient positioning system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5770 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Width — 80 Centimeter FDA UDIWidth — 120 Centimeter FDA UDILength — 230 Centimeter FDA UDI
Category: Vacuum-mould patient positioning system
VacQfix™ by Qfix — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vacuum-mould patient positioning system.
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- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
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- VacuumCushion Pos.Strip — MACROMEDICS B.V. · Class II
- Helping Hands ™ — Medtec LLC · Class II
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 |
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Manufacturer
- Manufacturer
- Qfix
Sources (1)
- FDA UDI 789c111e-04ab-4523-8773-c8bc9bd3e5fb 36 fields · synced Jun 8, 2026