Identity
- Trade Name
- Bausch + Lomb FDA UDI
- Generic Name
- Phacoemulsification/vitrectomy system FDA UDI
- Device Name
- TSV 25ga Combined Vitrectomy Pack with Valves and Wide Field Illuminator FDA UDI
- Model / Reference
- BL5325WV FDA UDI
- Description
- TSV 25ga Combined Vitrectomy Pack with Valves and Wide Field Illuminator FDA UDI
Identifiers
- Catalog Number
- BL5325WV FDA UDI
- Primary DI / UDI-DI
- 00757770058655 FDA UDI
- FDA Product Code
- HQE FDA UDI
- GMDN Term
- Phacoemulsification/vitrectomy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4150 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: Phacoemulsification/vitrectomy system
Bausch + Lomb by Bausch & Lomb Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Phacoemulsification/vitrectomy system.
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- EVA, combined machine including Laser (DORC connector) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- EVA, combined machine including Laser (DORC connector) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- EVA NEXUS™, Phaco emulsification system — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- EVA Mayo Arm. Accessory to EVA. — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- EVA, anterior machine — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- EVA NEXUS™, Phaco vitrectomy system including laser with SMA connector — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- Safety filter for Leica Microscopes, Manual — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
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 9b9fdcaf-211a-40aa-b1a9-b5976aa163b2 34 fields · synced Jun 8, 2026