Identity
- Trade Name
- MENDEC AQUA FDA UDI
- Generic Name
- Orthopaedic cement preparation/delivery kit FDA UDI
- Device Name
- MENDEC AQUA is a sterile single-use device for extrusion into the bone of acrylic resins or bone void fillers (not supplied with the kit) intended for vertebral augmentation procedures (vertebroplasty, kyphoplasty, screw-augmentation). FDA UDI
- Model / Reference
- ASC0020 FDA UDI
- Description
- MENDEC AQUA is a sterile single-use device for extrusion into the bone of acrylic resins or bone void fillers (not supplied with the kit) intended for vertebral augmentation procedures (vertebroplasty, kyphoplasty, screw-augmentation). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 28031497001702 FDA UDI
- FDA Product Code
- OAR FDA UDI
- GMDN Term
- Orthopaedic cement preparation/delivery kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic cement preparation/delivery kit
Mendec Aqua by Tecres — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Tecres
Sources (1)
- FDA UDI 0a5edee2-0f17-4d44-bc3f-dc0e4adb0da5 33 fields · synced Jun 8, 2026