Identity
- Trade Name
- MicroDose™ SF Injection Kit EUDAMEDMedOne FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
- Device Name
- Sterile cannula family of medical devices - cannulae, brushes, picks and related accessories (tubing, backflush devices and injection kits) for ophthalmic use. EUDAMED3315 MicroDoseTM SF Injection Kit FDA UDI
- Model / Reference
- 3315 EUDAMEDFDA UDI
- Description
- 3315 MicroDoseTM SF Injection Kit FDA UDI
Identifiers
- Catalog Number
- 3315 FDA UDI
- Primary DI / UDI-DI
- 00811313013157 EUDAMED10811313013154 FDA UDI
- Basic UDI-DI
- 081131301MEDSURG01QY EUDAMED
- Direct Marketing DI
- 00811313013157 EUDAMED
- 510(k) Number
- K203264 FDA UDI
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- Q021113 OPHTHALMIC SURGERY INSTRUMENT KITS, SINGLE-USE EUDAMED
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
Yes
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
MedOne by MedOne Surgical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
- I/A HDP. 45 W SLEEVE 1.8 12/BX — Bausch & Lomb, Inc. · Class II
- 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
Cleared under the same submission
K203264 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MedOne Surgical, Inc.
Sources (2)
- FDA UDI babea1ee-b977-4e93-a1a9-079e1757cc8e 36 fields · synced Jun 18, 2026
- EUDAMED e0e8c4d1-09ce-4e39-b5f3-3315848a5090 61 fields · synced Jun 18, 2026