Identity
- Trade Name
- ADTEC MONOPOLAR EUDAMEDAESCULAP FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- AdTec axial ring handle EUDAMEDAXIAL RING HANDLE ONLY RATCHET FDA UDI
- Model / Reference
- PM954R EUDAMEDFDA UDI
- Description
- AXIAL RING HANDLE ONLY RATCHET FDA UDI
Identifiers
- Catalog Number
- PM954R FDA UDI
- Primary DI / UDI-DI
- 04038653183661 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000002982L EUDAMED
- Direct Marketing DI
- 04038653183661 EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- L1203 LAPAROSCOPIC AND THORACOSCOPIC SURGERY MANIPULATORS, REUSABLE EUDAMED
- GMDN Term
- Surgical instrument handle, non-torque-limiting FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 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
No
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
Category: Surgical instrument handle, non-torque-limiting
Adtec Monopolar by Aesculap AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 40392390000002982L | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED 015d4625-e665-4d02-be02-04b335b20052 61 fields · synced Jul 28, 2026
- FDA UDI f15b0823-b73d-4426-bc97-830263e1c23c 35 fields · synced May 29, 2026