Identity
- Trade Name
- E4590 Belz Lacrimal Sac Rongeur EUDAMEDBelz Lacrimal Sac Rongeur FDA UDI
- Generic Name
- Ophthalmic surgical probe, reusable FDA UDI
- Device Name
- Reusable devices EUDAMED
- Model / Reference
- E4590 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04058935012762 EUDAMEDFDA UDI
- Basic UDI-DI
- 4058935-000000-AC EUDAMED
- Direct Marketing DI
- 04058935012762 EUDAMED
- FDA Product Code
- HNG FDA UDI
- EMDN Code
- L170401 CORNEAL TREPHINES, REUSABLE EUDAMED
- GMDN Term
- Ophthalmic surgical probe, 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Corneoscleral punch
E4590 Belz Lacrimal Sac Rongeur by Bausch & Lomb GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Corneoscleral punch.
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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 | 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 235488e1-2d28-40d4-a8fc-56f8851bf766 61 fields · synced Jul 8, 2026
- FDA UDI 1a2ab414-6171-4d38-bf69-14b8dd9c74fc 32 fields · synced May 30, 2026