E3388 GWL Gills-Welsh-Vannas Micro Scissors
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- E3388 GWL Gills-Welsh-Vannas Micro Scissors EUDAMEDGills-Welsh-Vannas Micro Scissors FDA UDI
- Generic Name
- Intraocular scissors, conventional-hinge, reusable FDA UDI
- Device Name
- Reusable devices EUDAMED
- Model / Reference
- E3388 GWL EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04058935012304 EUDAMEDFDA UDI
- Basic UDI-DI
- 4058935-000000-AC EUDAMED
- Direct Marketing DI
- 04058935012304 EUDAMED
- FDA Product Code
- HNF FDA UDI
- EMDN Code
- L01040510 CAPSULOTOMY SCISSORS, REUSABLE EUDAMED
- GMDN Term
- Intraocular scissors, conventional-hinge, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- Netherlands 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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Intraocular scissors, conventional-hinge, reusable
E3388 GWL Gills-Welsh-Vannas Micro Scissors by Bausch & Lomb GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4058935-000000-AC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bausch & Lomb GmbH
- EUDAMED SRN
- DE-MF-000009142
Sources (2)
- EUDAMED 095e8cd5-9175-4ccc-b11a-7d6b98b38d0c 61 fields · synced Jun 18, 2026
- FDA UDI 627c2932-986e-421e-b676-7f1e9ff8ddc3 32 fields · synced May 30, 2026