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UltraClean
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 139105EXTRef 139102Ref 139112Ref 139110EXT
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 1" (2.54 cm) Coated Needle with Extended Insulation FDA UDIULTRACLEAN ACCESSORY ELECTRODE, 6 INCH COATED BLADE WITH EXTENDED INSULATION FDA UDIUltraClean Accessory Electrode 4" (10.16 cm) Coated Blade FDA UDIUltraClean Accessory Electrode 1" (2.54 cm) Coated Needle FDA UDIUltraClean Accessory Electrode 6" (15.24 cm) Coated Blade with Extended Insulation FDA UDI
- Model / Reference
- 139105EXT EUDAMEDFDA UDI139102 EUDAMEDFDA UDI139112 EUDAMEDFDA UDI139110EXT EUDAMEDFDA UDI00602026000 FDA UDI
- Description
- UltraClean Accessory Electrode 1" (2.54 cm) Coated Needle with Extended Insulation FDA UDIULTRACLEAN ACCESSORY ELECTRODE, 6 INCH COATED BLADE WITH EXTENDED INSULATION FDA UDIUltraClean Accessory Electrode 4" (10.16 cm) Coated Blade FDA UDIUltraClean Accessory Electrode 1" (2.54 cm) Coated Needle FDA UDIUltraClean Accessory Electrode 6" (15.24 cm) Coated Blade with Extended Insulation FDA UDI
Identifiers
- Catalog Number
- 139105EXT FDA UDI139110EXT FDA UDI139112 FDA UDI139102 FDA UDI6020-260 FDA UDI
- Primary DI / UDI-DI
- 40653405033258 EUDAMEDFDA UDI10653405032458 EUDAMEDFDA UDI40653405007235 EUDAMEDFDA UDI40653405007341 EUDAMEDFDA UDI10653405007340 FDA UDI
- Basic UDI-DI
- B-40653405033258 EUDAMEDB-10653405032458 EUDAMEDB-40653405007235 EUDAMEDB-40653405007341 EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMEDK02030101 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
Yes
EUDAMEDEUDAMEDFDA 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
Dimensions & Sizes
- Size
- Length — 1 Inch FDA UDILength — 6 Inch FDA UDILength — 4 Inch FDA UDI
Category: Open-surgery electrosurgical electrode, monopolar, single-use
UltraClean by Conmed Corporation — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical electrode, monopolar, single-use.
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- star Bipolar RF Electrode — STARMED CO., LTD · Class IIb
- 4" Blade Tip Ext Ins; Stainless Steel; Blue Ins; Black Ext Ins — XODUS MEDICAL, INC. · Class II
- VIVA RF electrode — STARMED CO., LTD · Class IIb
- HT-DT-NTW45 — Zhejiang Jinhua Huatong Medical Appliance Co., Ltd · Class IIb
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-40653405033258 | 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 (12)
- EUDAMED 0c213217-ac73-4cfc-a529-95d90eb24b09 61 fields · synced Jul 27, 2026
- EUDAMED 3953fb6b-0a81-49f9-bffb-43188f800e0c 61 fields · synced May 18, 2026
- EUDAMED de1abf3f-1051-4260-babc-beca0140f906 61 fields · synced May 18, 2026
- FDA UDI b31a0c91-21ec-4395-a7cd-5cb25bca13c9 37 fields · synced May 30, 2026
- FDA UDI 0f590423-12e9-4193-b8d1-32fbfe4f60e1 37 fields · synced May 30, 2026
- FDA UDI 6102d0e7-e88c-4653-af5c-09cc100b119c 37 fields · synced May 30, 2026
- FDA UDI bab00b38-cc9a-4bc2-bcd7-31ef0601a797 36 fields · synced May 30, 2026
- FDA UDI 16f27052-48e8-4604-ae1d-91afa1a0191e 37 fields · synced May 30, 2026
- EUDAMED 0ce10545-d564-4412-8a04-bac81f3c9fa2 61 fields · synced Jul 10, 2026
- EUDAMED 5b74c2b0-3130-491a-8022-49586990c6d8 61 fields · synced Jul 18, 2026
- EUDAMED 94294c33-b57f-47aa-8c7a-9785db0e819c 61 fields · synced Jul 24, 2026
- EUDAMED 802bb243-d6bc-4295-9d67-bb438743887a 61 fields · synced Jul 27, 2026