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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 5 of 10

Device	Model / Reference	Registries	Class	Status
Disposable Backflush Handpiece 23g, Blunt Tip	S9.3012.23	FDA UDI	Class I	Active
EXTERNAL OCULID DARK BROWN® - 1, 6 g	S3.60164	FDA UDI	Class II	Active
Scleral buckling device, non-bioabsorbable	BAND (2.0 x 0.75 mm) TYPE 40	FDA UDI	Class II	Active
Vitrectomy contact lens, single-use	DISPOSABLE PMMA BICONCAVE LENS	FDA UDI	Class II	Active
OPHTACATH® 2 mm Kit Unilateral Kit	S1.4121	FDA UDI	U	Active
EXTERNAL OCULID TAN® - 1, 0 g	S3.60102	FDA UDI	Class II	Active
EXTERNAL OCULID MEDIUM BROWN® - 1, 6 g	S3.60163	FDA UDI	Class II	Active
Orbital sphere implant	BIOCERAMIC ORBITAL IMPLANT Ø 16 mm	FDA UDI	Class II	Active
OCULID PLATINUM SLIM® 1, 4 g	S3.6014	FDA UDI	Class II	Active
Disposable Blunt Tip Cannula 23g	S9.4112.23	FDA UDI	Class I	Active
Lacrimal punctum plug	READY-SET PUNCTUM PLUG (MICRO, 0.6)	FDA UDI	U	Active
Orbital sphere implant	ENUCLEATION EVISCERATION IMPLANT Ø 15 MM	FDA UDI	Class II	Active
Straight Illum Laser Probe, 27g Dorc & 19g Needle	S9.1405.27	FDA UDI	Class II	Active
OCULID GOLD 1, 4g	S3.3014	FDA UDI	Class II	Active
Widefield Light Probe 23g, & 19g Needle	S9.2101.23	FDA UDI	Class II	Active
Straight Illum Laser Probe, 23g Iridex/B&L & 19g Needle	S9.1401.23	FDA UDI	Class II	Active
FCI directional LASER PROBE / EXTENDABLE 25G QUANTEL	S9.1323.25	FDA UDI	Class II	Active
Scleral buckling device, non-bioabsorbable	4 X 3 mm ePTFE SPONGE (CHAUVAUD)	FDA UDI	Class II	Active
EXTERNAL OCULID PINK® - 1, 8 g	S3.60181	FDA UDI	Class II	Active
Disposable Soft Tip Cannula 23g	S9.4110.23	FDA UDI	Class I	Active
Disposable Backflush Handpiece 25g, Soft Tip	S9.3010.25	FDA UDI	Class I	Active
Vitrectomy contact lens, single-use	DISPOSABLE VITRECTOMY LENS	FDA UDI	Class II	Active
Straight Laser Probe, 25g Alcon/Coherent/Zeiss/Ellex/Os4	S9.1002.25	FDA UDI	Class II	Active
Scleral buckling device, non-bioabsorbable	STRIP (7.2 mm) TYPE 31	FDA UDI	Class II	Active
Disposible Cannula Brush Tip W	S9.4111.27	FDA UDI	Class I	Active
Orbital sphere implant	ENUCLEATION EVISCERATION IMPLANT Ø 16 MM	FDA UDI	Class II	Active
Straight Laser Probe, 25g Dorc	S9.1005.25	FDA UDI	Class II	Active
Scleral buckling device, non-bioabsorbable	SPONGE Ø 3 mm TYPE 503	FDA UDI	Class II	Active
Lacrimal tube	INFANT BIKA BICANALICULUS INTUBATION J.A. BERNARD, M.D.	FDA UDI	U	Active
OCULID GOLD SLIM 1, 2g	S3.4012	FDA UDI	Class II	Active
90° Adjustable Laser Probe, 23g Iridex/B&L	S9.1301.23	FDA UDI	Class II	Active
Orbital sphere implant	BIOCERAMIC ORBITAL IMPLANT Ø 18 mm	FDA UDI	Class II	Active
Orbital sphere implant	BIOCERAMIC ORBITAL IMPLANT Ø 14 mm	FDA UDI	Class II	Active
Lacrimal tube	PVP MONO-CRAWFORD MEDIUM COLLARETTE B. FAYET, MD	FDA UDI	U	Active
Disposable Backflush Handpiece 20g, Blunt Tip	S9.3012.20	FDA UDI	Class I	Active
Disposable Brush Tip Cannula 20g	S9.4111.20	FDA UDI	Class I	Active
OCULID GOLD 2, 4g	S3.3024	FDA UDI	Class II	Active
Autostable Bicanaliculus Intubation Set Ii (35 Mm) With Dilator	S1.1392	FDA UDI	U	Active
Orbital sphere implant	MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT (22 mm)	FDA UDI	Class II	Active
Straight Illum Laser Probe, 23g Nidek & 19g Needle	S9.1404.23	FDA UDI	Class II	Active
Disposable Cannula Soft Tip Wi	S9.4110.27	FDA UDI	Class I	Active
Flex Curved Laser Probe, 23g Dorc	S9.1215.23	FDA UDI	Class II	Active
OCULID PLATINUM SLIM® 1, 4 g	S3.6014	FDA UDI	Class II	Active
OCULID GOLD SLIM 1, 4g	S3.4014	FDA UDI	Class II	Active
Silicone Conformer (flexible)	S6.2001	FDA UDI	Class II	Active
Scleral buckling device, non-bioabsorbable	HALF-SPONGE 2.5 x 5 TYPE 510	FDA UDI	Class II	Active
Scleral buckling device, non-bioabsorbable	FIXATION SLEEVE FOR S5.1015U TYPE 71	FDA UDI	Class II	Active
Straight Illum Laser Probe, 27g Quantel & 19g Needle	S9.1403.27	FDA UDI	Class II	Active
Disposable Backflush Handpiece 20g, Diamond Dusted Soft Tip	S9.3013.20	FDA UDI	Class I	Active
OCULID GOLD SLIM 1, 6 g	S3.4016	FDA UDI	Class II	Active

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