Identity
- Trade Name
- 25GA Bipolar Eraser tapered EUDAMEDBipolar Pencil Tapered FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- Reusable Bipolar Instruments EUDAMEDMedical Device for Ophthalmic Surgery FDA UDI
- Model / Reference
- E7920 EUDAMEDFDA UDI
- Description
- Medical Device for Ophthalmic Surgery FDA UDI
Identifiers
- Catalog Number
- E7920 FDA UDI
- Primary DI / UDI-DI
- 04058935000660 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04058935000660 EUDAMED
- FDA Product Code
- GXI FDA UDI
- EMDN Code
- L031306 HEMOSTATIC FORCEPS, REUSABLE EUDAMED
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4725 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
25GA Bipolar Eraser tapered by Bausch & Lomb GmbH — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04058935000660 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Bausch & Lomb GmbH
- EUDAMED SRN
- DE-MF-000009142
Sources (2)
- EUDAMED 53c58499-0b6a-4da7-a672-65c6c1a20959 61 fields · synced Jun 18, 2026
- FDA UDI 20a8f818-c8b7-4bde-bd53-b00151fbad04 34 fields · synced May 30, 2026