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FCI S A S FCI 20 22

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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 800-932-4202
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 763408366

Catalogue (455)

Page 6 of 10

Device	Model / Reference	Registries	Class	Status
90° Adjustable Laser Probe, 25g Alcon/Coherent/Zeiss/Ellex/Os4	S9.1302.25	FDA UDI	Class II	Active
FCI directional LASER PROBE / EXTENDABLE 23G IRIDEX/B&L	S9.1321.23	FDA UDI	Class II	Active
Lacrijet® 45	S1.1545	FDA UDI	U	Active
Surgical depth gauge, single-use	SIZER FOR SELF-RETAINING BICANALICULUS INTUBATION	FDA UDI	Class I	Active
EZYPOR® Ø 12 mm	S6.6012	FDA UDI	Class II	Active
EXTERNAL OCULID MEDIUM BROWN® - 0, 6 g	S3.60063	FDA UDI	Class II	Active
Straight Laser Probe, 23g Alcon/Coherent/Zeiss/Ellex/Os4	S9.1002.23	FDA UDI	Class II	Active
Orbital sphere implant introducer	SPHERE INTRODUCER	FDA UDI	Class I	Active
Disposable End-Grasping Forceps, 25g	S9.6013.25	FDA UDI	Class I	Active
EZYPOR® Ø 14 mm	S6.6014	FDA UDI	Class II	Active
Lacrimal punctum plug	PRE-LOADED PVP MINI PERFORATED PLUG J.A. BERNARD, M.D.	FDA UDI	U	Active
Straight Laser Probe, 27g Dorc	S9.1005.27	FDA UDI	Class II	Active
Lacrimal tube	PVP MONO-CRAWFORD WIDE COLLARETTE B. FAYET, MD	FDA UDI	U	Active
Flex Curved Laser Probe, 23g Alcon/Coherent/Zeiss/Ellex/Os4	S9.1212.23	FDA UDI	Class II	Active
Flex Curved Laser Probe Compatible With Nidek Thread 27 G	S9.1214.27	FDA UDI	Class II	Active
Ophthalmic conformer	PERFORATED CONFORMER MEDIUM SIZE	FDA UDI	Class II	Active
TearSaver® - 0.7 mm	S2.3872	FDA UDI	U	Active
OCULID PLATINUM SLIM® 0, 8 g	S3.6008	FDA UDI	Class II	Active
OPHTACATH® 2 mm Unilateral Kit	S1.4121	FDA UDI	U	Active
Lacrimal punctum plug	READY-SET PUNCTUM PLUG (SLIM MINI, 0.4-SL)	FDA UDI	U	Active
Lacrimal punctum plug	PUNCTUM PLUGS - VARIETYPACK (0.4-SL, 0.5-SL, 0.6, 0.7) J. A. BERNARD, M.D.	FDA UDI	U	Active
OPHTACATH® 3 mm Bilateral Kit	S1.4132	FDA UDI	U	Active
OCULID PLATINUM SLIM® 1, 2 g	S3.6012	FDA UDI	Class II	Active
Surgical depth gauge, reusable	PUNCTAL GAUGES FOR PLUG S2.3422U AND S2.3122U	FDA UDI	Class I	Active
Disposable Dual Bore Cannula 20g	S9.4113.20	FDA UDI	Class I	Active
Orbital sphere implant	ENUCLEATION EVISCERATION IMPLANT Ø 22 MM	FDA UDI	Class II	Active
Scleral buckling device, non-bioabsorbable	BAND (4.0 x 1.25 mm) TYPE 42	FDA UDI	Class II	Active
EXTERNAL OCULID LIGHT® - 1, 4 g	S3.60140	FDA UDI	Class II	Active
Scleral buckling device, non-bioabsorbable	BICONVEX TIRE 9 TYPE 287	FDA UDI	Class II	Active
T.curved Illum Laser Probe, 25g Nidek & 19g Needle	S9.1604.25	FDA UDI	Class II	Active
90° Adjustable Laser Probe, 23g Nidek	S9.1303.25	FDA UDI	Class II	Active
EXTERNAL OCULID MEDIUM BROWN® - 1, 0 g	S3.60103	FDA UDI	Class II	Active
Symblepharon Ring 25 Mm	S6.2425	FDA UDI	Class II	Active
Scleral buckling device, non-bioabsorbable	ePTFE SPONGE 3.0 X 5.0 mm	FDA UDI	Class II	Active
Straight Illum Laser Probe, 20g Alc/Coh/Zeiss/Ellex/Os4&19g N.	S9.1402.20	FDA UDI	Class II	Active
Focus Light Probe 23g, & 19g Needle	S9.2001.23	FDA UDI	Class II	Active
EXTERNAL OCULID DARK BROWN® - 0, 8 g	S3.60084	FDA UDI	Class II	Active
Lacrijet® 35	S1.1535	FDA UDI	U	Active
Disposable Dual Bore Cannula 25g	S9.4113.25	FDA UDI	Class I	Active
Disposable Horizontal Scissors, 23g	S9.6014.23	FDA UDI	Class I	Active
Lacrimal tube	MONO-CRAWFORD WIDE COLLARETTE B. FAYET, MD	FDA UDI	U	Active
OCULID GOLD SLIM® 1, 6 g	S3.4016	FDA UDI	Class II	Active
Iris Retractors	S9.5015	FDA UDI	Class I	Active
Focus Light Probe 27g, & 19g Needle	S9.2001.27	FDA UDI	Class II	Active
Curved Laser Probe, 20g Nidek	S9.1104.20	FDA UDI	Class II	Active
Curved Laser Probe, 25g Nidek	S9.1204.25	FDA UDI	Class II	Active
Curved Laser Probe, 27g Quantel	S9.1213.27	FDA UDI	Class II	Active
Lacrijet® 40	S1.1540	FDA UDI	U	Active
Eyelid weight, implantable	PTOSIS SLING SET LLOUQUET & GUERIN, M. D.	FDA UDI	Class I	Active
Lacrimal tube	PVP RITLENG BICANALICULUS INTUBATION	FDA UDI	U	Active

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