Identity
- Trade Name
- Sutter FDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- Monopolar Electrodes single-use EUDAMEDARROWtip™ single-use Electrode 53mm,Ø0,3mm,45°short angled,shaft Ø2.4mm UOM = 10 pieces single-use FDA UDI
- Model / Reference
- 364421 EUDAMEDFDA UDI
- Description
- ARROWtip™ single-use Electrode 53mm,Ø0,3mm,45°short angled,shaft Ø2.4mm UOM = 10 pieces single-use FDA UDI
Identifiers
- Catalog Number
- 364421 FDA UDI
- Primary DI / UDI-DI
- ESUM3644210 EUDAMEDFDA UDI
- Basic UDI-DI
- ++ESUMTD22364400DQ EUDAMED
- FDA Product Code
- GEI 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
No
Implantable
No
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
No
Manufacturing Date
No
Category: Open-surgery electrosurgical electrode, monopolar, single-use
Sutter by Sutter Medizintechnik GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sutter Medizintechnik GmbH
Sources (2)
- FDA UDI 57f94b18-b425-4ef2-95a7-ddcd7b8a6f11 35 fields · synced Aug 2, 2026
- EUDAMED bd4545c9-384e-4093-b81d-b893f9303a47 61 fields · synced Aug 2, 2026