Identity
- Trade Name
- TruPWR Torque Limiting Attachment Sterile, Single-Use EUDAMEDTruPWR Torque Limiting Attachment, 12 Nm FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- TruPWR Torque Limiting Attachment Sterile, Single-Use EUDAMED
- Model / Reference
- 228-TXRX-001 EUDAMED12 Nm FDA UDI
Identifiers
- Catalog Number
- 228-TXRX-001 FDA UDI
- Primary DI / UDI-DI
- 00857676008348 EUDAMEDFDA UDI
- Basic UDI-DI
- 0857676008RA958878 EUDAMED
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Orthopaedic surgical procedure kit, non-medicated, single-use
TruPWR Torque Limiting Attachment, 12 Nm by Eca Medical Instruments — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | N/A | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Eca Medical Instruments
Sources (2)
- FDA UDI 7d44d3bc-afa6-4be9-a5d1-2d7e08a6890c 33 fields · synced Jul 17, 2026
- EUDAMED 3ddef3f8-29b2-4e2e-a03d-212fba56ef3b 61 fields · synced Jul 17, 2026