Identity
- Trade Name
- DISPOSABLE BACKFLUSH HANDPIECE 27G, BLUNT TIP FDA UDI
- Generic Name
- Vitrectomy fluid/gas handling handpiece/cannula FDA UDI
- Device Name
- DISPOSABLE BACKFLUSH HANDPIECE 27G, BLUNT TIP FDA UDI
- Model / Reference
- S9.3012.27 FDA UDI
- Description
- DISPOSABLE BACKFLUSH HANDPIECE 27G, BLUNT TIP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 13700773721105 FDA UDI
- FDA Product Code
- HMX FDA UDI
- GMDN Term
- Vitrectomy fluid/gas handling handpiece/cannula 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Vitrectomy fluid/gas handling handpiece/cannula
Disposable Backflush Handpiece 27g, Blunt Tip by Fci S A S Fci 20 22 — Class I — FDA UDI — listed in FDA GUDID — 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 (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
- Fci S A S Fci 20 22
Sources (1)
- FDA UDI 0ad30af0-e1d2-41d5-bb6b-b1598a2826c2 33 fields · synced Jun 8, 2026