Identity
- Trade Name
- VacQfix™ FDA UDI
- Generic Name
- Vacuum-mould patient positioning system FDA UDI
- Device Name
- VacQfix Cushion 70 x 230 , 65L fill FDA UDI
- Model / Reference
- RT-4517-70230F65F FDA UDI
- Description
- VacQfix Cushion 70 x 230 , 65L fill FDA UDI
Identifiers
- Catalog Number
- RT-4517-70230F65F FDA UDI
- Primary DI / UDI-DI
- 10841962108383 FDA UDI
- 510(k) Number
- K060671 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
- Not 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 — 70 Centimeter FDA UDITotal Volume — 65 Liter FDA UDILength — 230 Centimeter FDA UDI
VacQfix™ by Qfix — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K060671 also covers:
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 edfdabc8-b1bd-4b80-8189-b94feefc36a8 38 fields · synced May 30, 2026