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Double Offset Left Woodpecker Adaptor M2 Connection
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 9095.11.056
Identity
- Trade Name
- Double Offset Left Woodpecker Adaptor M2 Connection EUDAMEDFDA UDI
- Generic Name
- Surgical power tool adaptor FDA UDI
- Device Name
- Powered Impactors EUDAMEDA surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure FDA UDI
- Model / Reference
- 9095.11.056 EUDAMEDFDA UDI
- Description
- A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure FDA UDI
Identifiers
- Catalog Number
- 9095.11.056 FDA UDI
- Primary DI / UDI-DI
- 09421028112956 EUDAMEDFDA UDI
- Basic UDI-DI
- 942102811GMN00342A EUDAMED
- Direct Marketing DI
- 09421028112956 EUDAMED
- FDA Product Code
- HWE FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical power tool adaptor FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Double Offset Left Woodpecker Adaptor M2 Connection by Enztec Limited — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 942102811GMN00342A | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Enztec Limited
- EUDAMED SRN
- NZ-MF-000002264
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 144d2628-39e0-4a86-a3a5-6d4d229691fd 61 fields · synced Jul 19, 2026
- FDA UDI 6032d347-3332-43de-96c8-76ea3ea0ecdc 34 fields · synced May 30, 2026