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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 7 of 10

Device	Model / Reference	Registries	Class	Status
Ophthalmic trocar	RETILOCK® 25G NON VALVED SELF-RETAINING TROCAR	FDA UDI	Class I	Active
Orbital sphere implant	BIOCERAMIC ORBITAL IMPLANT Ø 12 mm	FDA UDI	Class II	Active
Symblepharon Ring 20 Mm	S6.2420	FDA UDI	Class II	Active
Scleral buckling device, non-bioabsorbable	SPONGE 3 x 5 TYPE 506	FDA UDI	Class II	Active
Straight Illum Laser Probe, 25g Alc/Coh/Zeiss/Ellex/Os4&19g N.	S9.1402.25	FDA UDI	Class II	Active
Scleral buckling device, non-bioabsorbable	ePTFE SPONGE 4 mm	FDA UDI	Class II	Active
EXTERNAL OCULID PINK® - 1, 4 g	S3.60141	FDA UDI	Class II	Active
Disposable Serrated Forceps 25g	S9.6011.25	FDA UDI	Class I	Active
Orbital sphere implant	MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT (16 mm)	FDA UDI	Class II	Active
Fci Nunchaku 90	S1.1361	FDA UDI	U	Active
FCI directional LASER PROBE / EXTENDABLE 23G ALCO/COH/ZEISS/ELLEX/OS4	S9.1322.23	FDA UDI	Class II	Active
Ritleng+	S1.1455	FDA UDI	U	Active
Ophthalmic soft-tissue surgical forceps, probe-like, reusable	ENDONASAL FORCEPS	FDA UDI	Class I	Active
Scleral buckling device, non-bioabsorbable	TIRE 11 TYPE 279	FDA UDI	Class II	Active
Lacrimal punctum plug	PRE-LOADED PVP PERFORATED PLUG J.A. BERNARD, M.D.	FDA UDI	U	Active
Disposable Backflush Handpiece	S9.3010.27	FDA UDI	Class I	Active
Ritleng Hook	S1.1480	FDA UDI	Class I	Active
Shielded Widefield Light Probe 20g, & 19g Needle	S9.2201.20	FDA UDI	Class II	Active
Shielded Widefield Light Probe 23g, & 19g Needle	S9.2201.23	FDA UDI	Class II	Active
EXTERNAL OCULID TAN® - 1, 4 g	S3.60142	FDA UDI	Class II	Active
Focus Light Probe 20g, & 19g Needle	S9.2001.20	FDA UDI	Class II	Active
OPHTACATH® 3 mm Unilateral Kit	S1.4131	FDA UDI	U	Active
Scleral buckling device, non-bioabsorbable	HALF-SPONGE 2.75 x 7.5 TYPE 511	FDA UDI	Class II	Active
Scleral buckling device, non-bioabsorbable	STRIP (8 mm) TYPE 225	FDA UDI	Class II	Active
OCULID GOLD 1.8g	S3.3018	FDA UDI	Class II	Active
Orbital sphere implant	ENUCLEATION EVISCERATION IMPLANT Ø 18 MM	FDA UDI	Class II	Active
Disposable End-Grasping Forceps, 23g	S9.6013.23	FDA UDI	Class I	Active
Lacrimal tube	MASTERKA ® 30 (DESIGNER B. FAYET, M.D.)	FDA UDI	U	Active
Ophthalmic conformer	PERFORATED CONFORMER LARGE SIZE	FDA UDI	Class II	Active
T.curved Illum Laser Probe, 23g Quantel & 19g Needle	S9.1603.23	FDA UDI	Class II	Active
OPHTACATH® 2 mm Kit Bilateral Kit	S1.4122	FDA UDI	U	Active
Straight Illum Laser Probe, 27g Nidek & 19g Needle	S9.1404.27	FDA UDI	Class II	Active
Disposable Dual Bore Cannula 23g	S9.4113.23	FDA UDI	Class I	Active
OCULID GOLD 2, 0g	S3.3020	FDA UDI	Class II	Active
OCULID GOLD SLIM 1, 0g	S3.4010	FDA UDI	Class II	Active
Lacrimal punctum plug	PUNCTUM PLUGS - SLIM PACK (SLIM PETITE, 0.5-SL) J. A. BERNARD, M.D.	FDA UDI	U	Active
Eyelid weight, implantable	PTOSE-UP 2 mm WIDTH J.M. RUBAN M.D.	FDA UDI	Class I	Active
Scleral buckling device, non-bioabsorbable	GROOVED SPONGE Ø 5 mm TYPE 505 G	FDA UDI	Class II	Active
Tano Polisher, 20g	S9.6016.20	FDA UDI	Class I	Active
Orbital sphere implant	BIOCERAMIC ORBITAL IMPLANT Ø 22 mm	FDA UDI	Class II	Active
Curved Laser Probe, 23g Nidek	S9.1204.23	FDA UDI	Class II	Active
Disposable Cannula Blunt Tip w	S9.4112.27	FDA UDI	Class I	Active
OCULID PLATINUM SLIM® 0, 6 g	S3.6006	FDA UDI	Class II	Active
Flex Curved Laser Probe, 25g Dorc	S9.1215.25	FDA UDI	Class II	Active
Sizers Set (enucleation / Evisceration) Single Use	S6.3060	FDA UDI	Class II	Active
Lacrimal tube	MONO-CRAWFORD WIDE COLLARETTE B. FAYET, MD	FDA UDI	U	Active
Scleral buckling device, non-bioabsorbable	STRIP (7.5 mm) TYPE 220	FDA UDI	Class II	Active
Disposable Tano Forceps 25g	S9.6017.25	FDA UDI	Class I	Active
Curved Laser Probe, 25g Iridex/B&L	S9.1201.25	FDA UDI	Class II	Active
90° Adjustable Laser Probe, 23g Nidek	S9.1304.23	FDA UDI	Class II	Active

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