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FCI 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
—
LinkedIn
—
Facebook
—
Phone
800-932-4202
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
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DUNS Number
763408366

Catalogue (455)

Page 8 of 10
DeviceModel / ReferenceRegistriesClassStatus
Curved Laser Probe, 23g Iridex/B&L S9.1201.23
FDA UDI
Class IIActive
pince super grip 25G S9.6018.25
FDA UDI
Class IActive
PRECIVIA® Version P S5.200.P
FDA UDI
Class IActive
General-purpose ophthalmic hook, reusable CRAWFORD HOOK
FDA UDI
Class IActive
Curved Laser Probe, 20g Dorc S9.1105.20
FDA UDI
Class IIActive
Crawford Hook S1.1275
FDA UDI
Class IActive
FCI directional LASER PROBE 25G NIDEK S9.1314.25
FDA UDI
Class IIActive
OCULID GOLD 1, 0g S3.3010
FDA UDI
Class IIActive
OPHTACATH® 2 mm Bilateral Kit S1.4122
FDA UDI
UActive
Straight Laser Probe, 27g Alcon/Coherent/Zeiss/Ellex/Os4 S9.1002.27
FDA UDI
Class IIActive
Lacrimal tube SELF-THREADING MONOKA WIDE COLLARETTE FAYET, BERNARD, RITLENG
FDA UDI
UActive
Straight Laser Probe, 23g Nidek S9.1004.23
FDA UDI
Class IIActive
EXTERNAL OCULID TAN® - 1, 2 g S3.60122
FDA UDI
Class IIActive
Curved Laser Probe, 23g Quantel S9.1203.23
FDA UDI
Class IIActive
EXTERNAL OCULID LIGHT® - 1, 2 g S6.60120
FDA UDI
Class IIActive
Straight Illum Laser Probe, 23g Alc/Coh/Zeiss/Ellex/Os4&19g N. S9.1402.23
FDA UDI
Class IIActive
EZYPOR® Ø 16 mm S6.6016
FDA UDI
Class IIActive
Lacrimal punctum plug READY-SET PUNCTUM PLUG (SLIM PETIT, 0.5-SL)
FDA UDI
UActive
OCULID GOLD SLIM 0, 8g S3.4008
FDA UDI
Class IIActive
Lacrimal tube PVP MONO-CRAWFORD WIDE COLLARETTE B. FAYET, MD
FDA UDI
UActive
Lacrimal punctum plug READY-SET PUNCTUM PLUG (MINI, US 0.7)
FDA UDI
UActive
OCULID PLATINUM SLIM® 1, 2 g S3.6012
FDA UDI
Class IIActive
Straight Laser Probe, 27g Iridex/B&L S9.1001.27
FDA UDI
Class IIActive
Straight Illum Laser Probe, 20g Quantel & 19g Needle S9.1403.20
FDA UDI
Class IIActive
TearSaver® - 0.6 mm S2.3862
FDA UDI
UActive
Straight Illum Laser Probe, 23g Quantel & 19g Needle S9.1403.23
FDA UDI
Class IIActive
Ritleng Probe S1.1460
FDA UDI
UActive
Curved Illum Laser Probe, 20g Dorc & 19g Needle S9.1505.20
FDA UDI
Class IIActive
Scleral buckling device, non-bioabsorbable ePTFE SPONGE 3 mm
FDA UDI
Class IIActive
OCULID GOLD SLIM 0, 8g S3.4008
FDA UDI
Class IIActive
Disposable Blunt Tip Cannula 25g S9.4112.25
FDA UDI
Class IActive
OCULID GOLD SLIM 1, 4 g S3.4014
FDA UDI
Class IIActive
T.curved Illum Laser Probe, 25g Iridex/B&L & 19g Needle S9.1601.25
FDA UDI
Class IIActive
Straight Laser Probe, 23g Iridex/B&L S9.1001.23
FDA UDI
Class IIActive
EXTERNAL OCULID LIGHT® - 1, 8 g S3.60180
FDA UDI
Class IIActive
OCULID GOLD SLIM 0, 6g S3.4006
FDA UDI
Class IIActive
Disposable Backflush Handpiece S9.3013.27
FDA UDI
Class IActive
Flex Curved Laser Probe, 25g Iridex/B&L S9.1211.25
FDA UDI
Class IIActive
Ophthalmic trocar RETILOCK® 25G VALVED SELF-RETAINING TROCAR
FDA UDI
Class IActive
Scleral buckling device, non-bioabsorbable STRIP (9.2 mm) TYPE 32
FDA UDI
Class IIActive
Flex Curved Laser Probe, 25g Alcon/Coherent/Zeiss/Ellex/Os4 S9.1212.25
FDA UDI
Class IIActive
Disposable Backflush Handpiece 25g, Diamond Dusted Soft Tip S9.3013.25
FDA UDI
Class IActive
EXTERNAL OCULID PINK® - 1, 0 g S3.60101
FDA UDI
Class IIActive
Straight Laser Probe, 23g Quantel S9.1003.23
FDA UDI
Class IIActive
Ophthalmic conformer PERFORATED CONFORMER SMALL SIZE
FDA UDI
Class IIActive
Lacrimal tube PVP RITLENG BICANALICULUS INTUBATION
FDA UDI
UActive
Straight Illum Laser Probe, 25g Quantel & 19g Needle S9.1403.25
FDA UDI
Class IIActive
OCULID GOLD 1, 6g S3.3016
FDA UDI
Class IIActive
Straight Illum Laser Probe, 27g Alc/Coh/Zeiss/Ellex/Os4&19g N. S9.1402.27
FDA UDI
Class IIActive
OCULID GOLD SLIM 1, 2g S3.4012
FDA UDI
Class IIActive

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