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Sign in to claim this brandFCI S A S FCI 20 22
US
Last updated May 24, 2026
What FCI S A S FCI 20 22 makes
The manufacturer produces ophthalmic laser system beam guides, including curved and tapered illuminated probes for various gauge needles, designed for precision laser applications in eye surgery. Their portfolio also includes external and implantable eyelid weights, such as the Symblepharon Ring and External Occluders in different weights and colors, as well as non-bioabsorbable scleral buckling devices for retinal repair. Additional products encompass vitrectomy fluid/gas handling handpieces and cannulas, lacrimal tubes and punctum plugs for tear duct management, and orbital sphere implants for prosthetic eye applications. The company also supplies single-use vitrectomy contact lenses and adhesive strips for surgical site management.
The device portfolio is regulated under FDA’s UDI system, with products classified as Class I, Class II, and Unclassified (U). These devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations. The manufacturer operates from the United States, adhering to applicable domestic regulatory requirements for each device class.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- fci-ophthalmics.com
- —
- —
- [email protected]
- Phone
- 800-932-4202
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 763408366
Catalogue (455)
Page 3 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| EXTERNAL OCULID PINK® - 1, 6 g | S3.60161 | FDA UDI | Class II | Active |
| Disposable Vertical Scissors, 23g | S9.6015.23 | FDA UDI | Class I | Active |
| 90° Adjustable Laser Probe, 23g Quantel | S9.1303.23 | FDA UDI | Class II | Active |
| OCULID GOLD 1, 8g | S3.3018 | FDA UDI | Class II | Active |
| EXTERNAL OCULID DARK BROWN® - 0, 6 g | S3.60064 | FDA UDI | Class II | Active |
| OCULID GOLD 2, 6g | S3.3026 | FDA UDI | Class II | Active |
| Straight Laser Probe, 20g Alcon/Coherent/Zeiss/Ellex/Os4 | S9.1002.20 | FDA UDI | Class II | Active |
| Disposable Backflush Handpiece 27g, Blunt Tip | S9.3012.27 | FDA UDI | Class I | Active |
| FCI directional LASER PROBE 23G DORC | S9.1315.23 | FDA UDI | Class II | Active |
| Ophthalmic surgical procedure kit, non-medicated, single-use | SELF-BLOCKING VITRECTOMY INFUSION AND CANNULA SET | FDA UDI | Class II | Active |
| EZYPOR® Ø 18 mm | S6.6018 | FDA UDI | Class II | Active |
| Eyelid weight, implantable | PTOSE-UP 3 mm WIDTH J.M. RUBAN, M.D. | FDA UDI | Class I | Active |
| Half-Sponge 2.75 X 7.5 Type 511 | S5.6475 | FDA UDI | Class II | Active |
| EXTERNAL OCULID PINK® - 0, 6 g | S3.60061 | FDA UDI | Class II | Active |
| Curved Laser Probe, 20g Quantel | S9.1103.20 | FDA UDI | Class II | Active |
| Orbital sphere implant | EGG SHAPED BIOCERAMIC ORBITAL IMPLANT DIA. 18 MM | FDA UDI | Class II | Active |
| Lacrimal tube | PVP SELF-THREADING MONOKA FAYET, BERNARD, RITLENG | FDA UDI | U | Active |
| Bika® For Dcr | S1.1400 | FDA UDI | U | Active |
| Disposable Subretinal Cannula 25g | S9.4014.25 | FDA UDI | Class I | Active |
| Chandelier 25g | S9.2301.25 | FDA UDI | Class II | Active |
| Scleral buckling device, non-bioabsorbable | ASYMMETRICAL TIRE 9 TYPE 276 | FDA UDI | Class II | Active |
| 7 External Eyelid Weights Sizing Set | S3.7000 | FDA UDI | Class II | Active |
| Scleral buckling device, non-bioabsorbable | ePTFE SPONGE 2 X 5 mm | FDA UDI | Class II | Active |
| Scleral buckling device, non-bioabsorbable | GROOVED SPONGE 5.5 x 7.5 TYPE 507 G | FDA UDI | Class II | Active |
| Disposable Horizontal Scissors, 25g | S9.6014.25 | FDA UDI | Class I | Active |
| Orbital sphere implant | ENUCLEATION EVISCERATION IMPLANT Ø 19 MM | FDA UDI | Class II | Active |
| Ophthalmic surgical procedure kit, non-medicated, single-use | DISPOSABLE VITRECTOMY SET | FDA UDI | Class II | Active |
| OPHTACATH® 3 mm Kit Bilateral Kit | S1.4132 | FDA UDI | U | Active |
| Lacrimal tube | RITLENG BICANALICULUS INTUBATION | FDA UDI | U | Active |
| Lacrimal dilator, reusable | DOUBLE DILATOR | FDA UDI | Class I | Active |
| Lacrimal punctum plug | PUNCTUM PLUGS - SLIM PACK (SLIM-MINI 0.4-SL) J. A. BERNARD, M.D. | FDA UDI | U | Active |
| Lacrimal tube | MEDIUM COLLARETTE MONOKA ® BY FAYET & BERNARD ® | FDA UDI | U | Active |
| Curved Illum Laser Probe, 20g Nidek & 19g Needle | S9.1504.20 | FDA UDI | Class II | Active |
| Ocular Shield | S6.2301 | FDA UDI | Class I | Unknown |
| Maculorhexis Forceps 27 G | S9.6012.27 | FDA UDI | Class I | Active |
| Lacrijet® 15 | S1.1515 | FDA UDI | U | Active |
| Orbital sphere implant introducer | SPHERE INTRODUCER | FDA UDI | Class I | Active |
| Disposable Brush Tip Cannula 25g | S9.4111.25 | FDA UDI | Class I | Active |
| Lacrijet® 20 | S1.1522 | FDA UDI | U | Active |
| FCI directional LASER PROBE / EXTENDABLE 23G NIDEK | S9.1324.23 | FDA UDI | Class II | Active |
| EXTERNAL OCULID LIGHT® - 0, 8 g | S3.60080 | FDA UDI | Class II | Active |
| FCI directional LASER PROBE 25G ALCO/COH/ZEISS/ELLEX/OS4 | S9.1312.25 | FDA UDI | Class II | Active |
| Lacrimal probe, reusable | RITLENG NASO-LACRIMAL PROBE | FDA UDI | Class I | Active |
| Tano Polisher, 25g | S9.6016.25 | FDA UDI | Class I | Active |
| Straight Laser Probe, 25g Nidek | S9.1004.25 | FDA UDI | Class II | Active |
| Vitrectomy contact lens, single-use | DISPOSABLE PMMA VITRECTOMY LENS PLANOCONCAVE | FDA UDI | Class II | Active |
| Lacrimal tube | RITLENG BICANALICULUS INTUBATION | FDA UDI | U | Active |
| Flex Curved Laser Probe, 25g Nidek | S9.1214.25 | FDA UDI | Class II | Active |
| Lacrimal punctum plug | READY-SET PUNCTUM PLUG (SMALL, US 0.8) | FDA UDI | U | Active |
| OCULID PLATINUM SLIM® 1, 0 g | S3.6010 | FDA UDI | Class II | Active |
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