Identity
- Trade Name
- CONMED EUDAMEDFDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- Non-orthopedic, Active, Instrument, Electrosurgical, Electrode, Open, Uncoated, Disposable EUDAMEDCONMED ELECTROSURGICAL ACCESSORY, Loop Excision Electrode 15 mm x 10 mm FDA UDI
- Model / Reference
- 60-5180-102 EUDAMEDFDA UDI
- Description
- CONMED ELECTROSURGICAL ACCESSORY, Loop Excision Electrode 15 mm x 10 mm FDA UDI
Identifiers
- Catalog Number
- 60-5180-102 FDA UDI
- Primary DI / UDI-DI
- 30653405010221 EUDAMEDFDA UDI
- Basic UDI-DI
- B-30653405010221 EUDAMED
- 510(k) Number
- K925333 FDA UDI
- FDA Product Code
- HGI FDA UDI
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY 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
- 884.4120 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
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
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Open-surgery electrosurgical electrode, monopolar, single-use
Conmed by Conmed Corporation — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K925333 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
Sources (2)
- FDA UDI a0b5eee9-da53-4faf-807f-dfaeec931ddc 38 fields · synced Oct 5, 2026
- EUDAMED 27ec5808-870f-4ff5-98a8-730037f33261 61 fields · synced Oct 5, 2026