Identity
- Trade Name
- Bipolar Forceps EUDAMEDFDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- Bipolar Wand EUDAMEDBipolar Forceps reusable, Jeweler #5, 4 1/2", 0.5mm tip FDA UDI
- Model / Reference
- SDTFQM-40 EUDAMEDSBF-001-05 EUDAMEDFDA UDI
- Description
- Bipolar Forceps reusable, Jeweler #5, 4 1/2", 0.5mm tip FDA UDI
Identifiers
- Catalog Number
- SBF-001-05 FDA UDI
- Primary DI / UDI-DI
- 00810026181771 EUDAMEDFDA UDI
- Basic UDI-DI
- 0081002618SDTFQM-40TQ EUDAMED
- Direct Marketing DI
- 00810026181771 EUDAMED
- 510(k) Number
- K964176 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- L180401 OPEN ELECTROSURGERY FORCEPS, REUSABLE EUDAMED
- GMDN Term
- Open-surgery 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
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA 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
Yes
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Bipolar Forceps by Soniquence, LLC — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0081002618SDTFQM-40TQ | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Soniquence, LLC
- EUDAMED SRN
- US-MF-000029810
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED d01737d3-ee0d-43c8-9cfd-183d02ec68b3 61 fields · synced Aug 2, 2026
- FDA UDI 8c03418e-5fac-43e6-9e5f-30790305dfc1 35 fields · synced May 30, 2026