Identity
- Trade Name
- Guenter Bissinger Medizintechnik GmbH FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- NON-Stick bipolar forceps 215 mm bayonet 45° angl. up. 1,2 x 8.0 mm norm. classic blue insulated, 2-Pin Plug grey FDA UDI
- Model / Reference
- WER-8U FDA UDI
- Description
- NON-Stick bipolar forceps 215 mm bayonet 45° angl. up. 1,2 x 8.0 mm norm. classic blue insulated, 2-Pin Plug grey FDA UDI
Identifiers
- Catalog Number
- WER-8U FDA UDI
- Primary DI / UDI-DI
- 04250418750400 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
A comprehensive medical device that provides a convenient and effective way to perform electrosurgical procedures, featuring a rigid combined electrosurgical handpiece and bipolar electrode. It is designed for general plastic surgery and can be used in a variety of applications.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Günter Bissinger Medizintechnik GmbH
Sources (1)
- FDA UDI 63e14d04-8749-4013-8f47-710fa270d240 35 fields · synced Jul 16, 2026