Identity
- Trade Name
- UltraClean EUDAMEDFDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- Non-orthopedic, Active, Instrument, Electrosurgical, Electrode, Open, Coated, Disposable EUDAMEDUltraClean Accessory Electrode 6" (15.24 cm) Coated Blade FDA UDI
- Model / Reference
- 139107 EUDAMEDFDA UDI
- Description
- UltraClean Accessory Electrode 6" (15.24 cm) Coated Blade FDA UDI
Identifiers
- Catalog Number
- 139107 FDA UDI
- Primary DI / UDI-DI
- 10653405007302 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10653405007302 EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K02030101 RADIOFREQUENCY SURGERY ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
UltraClean by Conmed Corporation — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10653405007302 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED cb79c922-5a7d-4b59-bde6-796228d91d47 61 fields · synced May 30, 2026
- FDA UDI ae27f29a-ea7d-482a-84e0-5bc98a98b90e 36 fields · synced May 30, 2026