Identity
- Trade Name
- Sutter FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
- Device Name
- Bipolar FlexTip Electrodes Arthrex EUDAMEDFlexTip Bipolar electrodes single-use WL: 28cm, CURIS plug FDA UDI
- Model / Reference
- AR-S9805-0028 EUDAMEDFDA UDI
- Description
- FlexTip Bipolar electrodes single-use WL: 28cm, CURIS plug FDA UDI
Identifiers
- Catalog Number
- AR-S9805-0028 FDA UDI
- Primary DI / UDI-DI
- ESUMARS980500280 EUDAMEDFDA UDI
- Basic UDI-DI
- ++ESUMTD27ARS9805TT EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K0201010302 LAPAR AND THORACOSCOPIC ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, 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 handpiece/electrode, bipolar, single-use
Sutter by Sutter Medizintechnik GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical handpiece/electrode, bipolar, single-use.
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- Symmetry Olsen — Olsen Medical · Class II
- Symmetry Olsen — Olsen Medical · Class II
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 0da96484-9377-45f6-ab20-d8d46fdb077b 35 fields · synced Jun 18, 2026
- EUDAMED 18c08ed7-a672-435b-907b-f9407786f513 61 fields · synced Jun 18, 2026