Identity
- Trade Name
- OPERACE EUDAMEDFDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- Handles / Cross Handles EUDAMEDHandles used together with the sterile inserts for implant screw extraction FDA UDI
- Model / Reference
- 80002 EUDAMEDFDA UDI
- Description
- Handles used together with the sterile inserts for implant screw extraction FDA UDI
Identifiers
- Catalog Number
- 80002 FDA UDI
- Primary DI / UDI-DI
- 07610733800025 EUDAMED07610733850020 FDA UDI
- Basic UDI-DI
- 7610733MD47829CP EUDAMED
- Direct Marketing DI
- 07610733800025 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Surgical instrument handle, non-torque-limiting FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
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
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
Operace by Pb Swiss Tools Ag — Class I — 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 | 7610733MD47829CP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- PB Swiss Tools AG
- EUDAMED SRN
- CH-MF-000040741
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 79b1c8f3-d3e3-4039-861d-13019b3b351c 61 fields · synced Jul 9, 2026
- FDA UDI 61573f52-de55-453a-9997-047a254d3969 35 fields · synced May 30, 2026