Identity
- Trade Name
- I/A HDP.SIL.TIP STRT.STEL 1/B FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
- Device Name
- Single Use Medical Device for Ophthalmic Surgery FDA UDI
- Model / Reference
- 85912ST EA FDA UDI
- Description
- Single Use Medical Device for Ophthalmic Surgery FDA UDI
Identifiers
- Catalog Number
- 85912ST EA FDA UDI
- Primary DI / UDI-DI
- 04058935000400 FDA UDI
- FDA Product Code
- HQC FDA UDI
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4670 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
No
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
Yes
FDA UDI
Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
I/A Hdp.sil.tip Strt.stel 1/B by Bausch & Lomb, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use.
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- Universal PVC infusion line for 23G cannula system for VFI/VFE — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- Soft Tip Cannula 20g, 0.8mm tip — Psi/Eye-Ko, Inc. · Class IIa
- Visitec® — Beaver-Visitec International, Inc. · Class I
- 85784S 17GA I/A Handpiece, str., tip 45° angled — Bausch & Lomb GmbH · Class IIa
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- SURGISTAR — Surgistar Inc. · Class I
- Lasik Irrigator - 4 Ports — Hurricane Medical · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA UDI e64c738c-0853-4dc3-b5d2-98b69c4e943e 34 fields · synced Jun 8, 2026