Identity
- Trade Name
- Bausch + Lomb FDA UDI
- Generic Name
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- 25 ga. Bi-Blade Vitreous Cutter Posterior Wide-Field Stellaris Elite Pack FDA UDI
- Model / Reference
- SE5425WVB FDA UDI
- Description
- 25 ga. Bi-Blade Vitreous Cutter Posterior Wide-Field Stellaris Elite Pack FDA UDI
Identifiers
- Catalog Number
- SE5425WVB FDA UDI
- Primary DI / UDI-DI
- 10757770059772 FDA UDI
- FDA Product Code
- HQE FDA UDIHQC FDA UDI
- GMDN Term
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4150 FDA UDI886.4670 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Bausch + Lomb by Bausch & Lomb Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Bausch & Lomb Incorporated
Sources (1)
- FDA UDI 83b023cd-62c3-476a-a563-2740be6847a8 34 fields · synced Jun 8, 2026