Identity
- Trade Name
- Backflush FlexTip™ 27g EUDAMEDMedOne FDA UDI
- Generic Name
- Vitrectomy fluid/gas handling handpiece/cannula 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. EUDAMEDBackflush FlexTip™ 27g FDA UDI
- Model / Reference
- 3278 EUDAMEDFDA UDI
- Description
- Backflush FlexTip™ 27g FDA UDI
Identifiers
- Catalog Number
- 3278 FDA UDI
- Primary DI / UDI-DI
- 00811313012785 EUDAMED10811313012782 FDA UDI
- Basic UDI-DI
- 081131301MEDSURG01QY EUDAMED
- Direct Marketing DI
- 00811313012785 EUDAMED
- FDA Product Code
- HMX FDA UDI
- EMDN Code
- Q021101 OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE EUDAMED
- GMDN Term
- Vitrectomy fluid/gas handling handpiece/cannula FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Category: Vitrectomy fluid/gas handling handpiece/cannula
MedOne by MedOne Surgical, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Vitrectomy fluid/gas handling handpiece/cannula.
- Bausch + Lomb — Bausch & Lomb Incorporated · Class II
- Extendible brush backflush instrument with active aspiration. (23 gauge / 0.6 mm — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
- VitreQ — Vitreq B.V. · Class I
- Disposable Backflush instrument, with brush needle and active aspiration. — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
- Vortex Surgical Inc — Vortex Surgical, Inc. · Class I
- VitreQ — Vitreq B.V. · Class I
- Vortex Surgical Inc — Vortex Surgical, Inc. · Class I
- Backflush Instrument with 20 gauge / 0.9 mm brush needle. — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- MedOne Surgical, Inc.
Sources (2)
- FDA UDI b0dadc0a-f67b-4579-ba84-24711b4f38b7 35 fields · synced Jul 24, 2026
- EUDAMED 161226f7-b2a8-4f74-9b96-758202327eef 61 fields · synced Jul 24, 2026