Identity
- Trade Name
- Sutter FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- Bipolar Clamps EUDAMEDCalvian endo-pen® non-stick, bayonet, US 15°, WL 9cm, forceps style tip 0,7mm FDA UDI
- Model / Reference
- 700908SGS EUDAMEDFDA UDI
- Description
- Calvian endo-pen® non-stick, bayonet, US 15°, WL 9cm, forceps style tip 0,7mm FDA UDI
Identifiers
- Catalog Number
- 700908SGS FDA UDI
- Primary DI / UDI-DI
- ESUM700908SGS0 EUDAMEDFDA UDI
- Basic UDI-DI
- ++ESUMTD11700900C3 EUDAMED
- Direct Marketing DI
- ESUM700908SGS0 EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- L180401 OPEN ELECTROSURGERY FORCEPS, REUSABLE EUDAMED
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, bipolar, reusable 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
No
Single Use
No
Implantable
No
Reusable
Yes
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: Endoscopic electrosurgical handpiece/electrode, bipolar, reusable
Sutter by Sutter Medizintechnik GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electrosurgical handpiece/electrode, bipolar, reusable.
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Bipolar Clamps — SUTTER MEDIZINTECHNIK GMBH · Class IIb
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- V. Mueller — STERIS CORPORATION · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sutter Medizintechnik GmbH
Sources (2)
- FDA UDI 28d36f99-ba50-4457-ba65-010f87c0d1dc 35 fields · synced Jun 14, 2026
- EUDAMED 05aed3dd-e3fd-4308-adc9-b65570d9628b 61 fields · synced Jun 11, 2026