Identity
- Trade Name
- NUCLEUS Y-HOOK HORIZONTAL 12B FDA UDI
- Generic Name
- Ophthalmic surgical probe, single-use FDA UDI
- Device Name
- Single Use Medical Device for Ophthalmic Surgery FDA UDI
- Model / Reference
- SUF05 FDA UDI
- Description
- Single Use Medical Device for Ophthalmic Surgery FDA UDI
Identifiers
- Catalog Number
- SUF05 FDA UDI
- Primary DI / UDI-DI
- 04058935005184 FDA UDI
- FDA Product Code
- HND FDA UDI
- GMDN Term
- Ophthalmic surgical probe, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic surgical probe, single-use
Nucleus Y-Hook Horizontal 12b by Bausch & Lomb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic surgical probe, single-use.
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- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- HASA OPTIX — Hasa Optix · Class IIa
- HASA OPTIX — Hasa Optix · Class IIa
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- HASA OPTIX — Hasa Optix · Class IIa
- Epithelial Spatula — BLINK MEDICAL LIMITED · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA UDI a3774608-ed37-4eee-b1df-a20c41da0b52 34 fields · synced May 30, 2026