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Bipolar Wand
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref SDTFQM-31Model SDTFQM-40Ref SDTFQM-18Ref SDTFQ-36Ref SCBS-SRef SDTFQM-34Ref SDRY-MAN3Ref STF-SRef SDTFQM-32Ref SDTFQ-32Ref SCBS-ARef SDTFQ-38Ref SDTF-24Ref SDTFD-13Ref SDTFQ-13Ref SDTFQ-24BRef SDTFQ-24
Identity
- Trade Name
- Bipolar Wand EUDAMEDFDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
- Device Name
- Bipolar Wand EUDAMEDBipolar Wand, Sterile, Disposable, 24cm WL, 2.5mm Diameter FDA UDI
- Model / Reference
- SDTFQM-40 EUDAMEDSDTFQM-31 EUDAMEDSDTFQM-18 EUDAMEDSDTFQ-36 EUDAMEDSCBS-S EUDAMEDSDTFQM-34 EUDAMEDSDRY-MAN3 EUDAMEDSTF-S EUDAMEDSDTFQM-32 EUDAMEDSDTFQ-32 EUDAMEDSCBS-A EUDAMEDSDTFQ-38 EUDAMEDSDTF-24 EUDAMEDFDA UDISDTFD-13 EUDAMEDSDTFQ-13 EUDAMEDSDTFQ-24B EUDAMEDSDTFQ-24 EUDAMED
- Description
- Bipolar Wand, Sterile, Disposable, 24cm WL, 2.5mm Diameter FDA UDI
Identifiers
- Catalog Number
- SDTF-24 FDA UDI
- Primary DI / UDI-DI
- 00810026182341 EUDAMED00810026182310 EUDAMED00810026182266 EUDAMED00810026182471 EUDAMED00810026182365 EUDAMED00810026182488 EUDAMED00810026182440 EUDAMED00810026182358 EUDAMED00810026182235 EUDAMED00810026182464 EUDAMED00810026182273 EUDAMED00810026181221 EUDAMEDFDA UDI00810026182426 EUDAMED00810026182181 EUDAMED00810026182211 EUDAMED00810026182204 EUDAMED
- Basic UDI-DI
- 0081002618SDTFQM-40TQ EUDAMED
- 510(k) Number
- K190336 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Endoscopic 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
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Open-surgery electrosurgical electrode, monopolar, single-use
Bipolar Wand by Soniquence, LLC — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Open-surgery electrosurgical electrode, monopolar, single-use.
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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 (17)
- EUDAMED 795e46e4-5664-4264-a089-c37009dcb976 61 fields · synced Aug 1, 2026
- EUDAMED c8718a57-66e8-498e-b417-287d2623d404 61 fields · synced May 16, 2026
- EUDAMED c38eb549-dde2-42fd-95e0-c5dec49982f1 61 fields · synced May 17, 2026
- EUDAMED 0842a210-f2a7-4d31-9cda-d21cc723f4ba 61 fields · synced May 17, 2026
- EUDAMED a4dbff6d-6680-48ff-8c55-50e71342c130 61 fields · synced May 17, 2026
- EUDAMED a55eba8b-5486-4c2a-bb9b-4e0137518f0c 61 fields · synced May 18, 2026
- EUDAMED f3134041-1cf9-4dea-afc6-8fbc9732d50d 61 fields · synced May 18, 2026
- EUDAMED 2c63cc0a-9341-47dd-9e83-6f25e32eeeed 61 fields · synced May 18, 2026
- EUDAMED a6858ab9-340d-4590-9870-6a5c80c9c9bc 61 fields · synced May 18, 2026
- EUDAMED de3ab1ad-e43c-4b43-87c6-62aa9d760f87 61 fields · synced May 18, 2026
- EUDAMED f42e92b4-47dc-4809-9e84-91bd661158f1 61 fields · synced May 18, 2026
- EUDAMED 2507e997-2137-40b7-89ea-fd2ef96063d5 61 fields · synced May 18, 2026
- EUDAMED 3eed6d69-a75c-42ff-9527-298762f2fb13 61 fields · synced May 18, 2026
- EUDAMED e5df8b2a-4f55-4621-ba2a-841c65cd1b94 61 fields · synced May 18, 2026
- EUDAMED 1594fdb2-8fe4-4ad6-b982-3ec4469f7244 61 fields · synced May 19, 2026
- EUDAMED 95a009c2-4179-4bb6-9d49-5066080222c1 61 fields · synced May 19, 2026
- FDA UDI 85feeaa6-81b3-4fa4-b4f3-fb73d7283960 35 fields · synced May 30, 2026