FINE WIRE Needle Electrode
EUDAMEDFDA UDIClass IIb (EU MDR)
by Cynosure LLC
Identity
- Trade Name
- FINE WIRE Needle Electrode EUDAMEDFDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- FINE WIRE Needle Electrode EUDAMEDFINE WIRE -3/8" NEEDLE - 25PCS STERILE FDA UDI
- Model / Reference
- A2D EUDAMEDFDA UDI
- Description
- FINE WIRE -3/8" NEEDLE - 25PCS STERILE FDA UDI
Identifiers
- Catalog Number
- A2D FDA UDI
- Primary DI / UDI-DI
- 00841494103071 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00841494103071 EUDAMED
- FDA Product Code
- JOS 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
- 878.4400 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
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
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Open-surgery electrosurgical electrode, monopolar, single-use
FINE WIRE Needle Electrode by Cynosure, LLC — 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.
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC · Class II
- Symmetry Olsen — Olsen Medical · Class II
- FlexTrode® Malleable Electrode — ELLIQUENCE LLC · Class II
- 33cm Laparoscopic L-Wire Split; Blue PTFE; Black Insulation; PL — XODUS MEDICAL, INC. · Class II
- 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
- CONMED — Conmed Corporation · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00841494103071 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cynosure LLC
- EUDAMED SRN
- US-MF-000010200
- Authorised Representative
- Cynosure B.V. NL-AR-000009566
Sources (2)
- EUDAMED 967f0b34-c472-4f15-bf36-a4cac1293d7b 61 fields · synced Jul 12, 2026
- FDA UDI 93466ee8-e873-47f7-bf3d-91b9fe3c7143 34 fields · synced May 30, 2026