Identity
- Trade Name
- XTRUDER FDA UDI
- Generic Name
- Orthopaedic cement preparation/delivery kit FDA UDI
- Device Name
- XTRUDER is intended for extrusion of acrylic resins or bone void fillers prepared with Tecres SHAKIT. FDA UDI
- Model / Reference
- ASA0390 FDA UDI
- Description
- XTRUDER is intended for extrusion of acrylic resins or bone void fillers prepared with Tecres SHAKIT. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 28031497001436 FDA UDI
- FDA Product Code
- KIH 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
Xtruder by Tecres — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic cement preparation/delivery kit.
- PicoMix Syringe — G21 SRL · Class I
- MEDINAUT-Ix — IMEDICOM CO., LTD. · Class I
- Arthrex Bone Cement Mixing Syringe — G21 SRL · Class I
- Revolution — Stryker Corp. · Class I
- LITe BIO Delivery System — Stryker Corp. · Class II
- VORTEX — Smith & Nephew, Inc. · Class I
- StabiliT® — Merit Medical Systems, Inc. · Class II
- PicoMix Bowl — G21 SRL · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tecres
Sources (1)
- FDA UDI 64961c37-325e-4534-b6f6-09b01957d8a4 33 fields · synced Jun 1, 2026