FDA Registration Active 🇫🇷 France

FCI SAS

Reg #: 9615745 · FEI: 3000314405 · Expires 2026
Products
30
Proprietary Names
386
Establishment Types
4
Classifications
30

Registration Details

Registration Name
FCI SAS
Registration Number
9615745
FEI Number
3000314405
Status
Active
Expiry Year
2026
Initial Importer
No
Address
2 rue Carl Zeiss
City
BESANCON Doubs
Country
FR

Regulatory Submissions

510(k) Number
K964774

Owner / Operator

Firm Name
Carl Zeiss Meditec AG (Jena)
Operator Number
9053564
Address
Goeschwitzer Strasse 51-52
City
Jena
State
Thuringia
Postal Code
07745
Country
DE

US Agent

Business Name
CARL ZEISS MEDITEC USA, INC.
Contact Name
Paul Swift
Address
5300 Central Pkwy
City
Dublin
State
CA
ZIP
94568
Country
US
Phone
817 9258507

Products

Device Name Product Code
Plug, Punctum LZU
Weights, Eyelid, External MML
Conformer, Ophthalmic HQN
Weights, Eyelid, Implantable NCB
Cannula, Trocar, Ophthalmic NGY
Dilator, Lachrymal HNW
Probe, Lachrymal HNL
Hook, Ophthalmic HNQ
Gauge, Measuring JYJ
Specula, Ophthalmic HNC
Lacrimal Stents And Intubation Sets OKS
Implant, Eye Sphere HPZ
Catheter, Intravascular, Diagnostic DQO
Introducer, Sphere HNP
Crutch, Ptosis HJZ
Ocular Peg MQU
Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal MXY
Lens, Condensing, Diagnostic HJL
Expander, Tissue, Orbital NFM
Laser, Ophthalmic HQF
Endoilluminator MPA
Photocoagulator And Accessories HQB
Forceps, Ophthalmic HNR
Implant, Orbital, Extra-Ocular HQX
Spatula, Ophthalmic HND
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
Scissors, Ophthalmic HNF
Cannula, Ophthalmic HMX
Knife, Ophthalmic HNN
Lens, Contact, Polymethylmethacrylate, Diagnostic HJK

Proprietary Names

NON-STERILE PLUGS, SLIM PLUGS 0.4MM SLIM MINI NON-STERILE PLUGS, SLANTED COLLARETTE PLUGS 0.7MM MINI NON-STERILE PLUGS, VARIETY PACK ASSORTED 6 PLUGS EACH NON-STERILE PLUGS, SLIM PLUGS 0.5MM SLIM PETITE Non-Sterile Plugs NON-STERILE PLUGS, SLANTED COLLARETTE PLUGS 0.6MM MICRO FCI External Eyelid Weight Blinkeze Eyelid Weight OCULID External Eyelid Weights Hypoallergenic Adhesive Strips OCULID Sizing Set Tantalum Eyelid Weight Sizing Set PERFORATED CONFORMERS, 26MM LARGE SILICONE CONFORMER SYMBLEPHARON RINGS, 25MM LARGE SYMBLEPHARON RINGS, 20MM SMALL SYMBLEPHARON RINGS, 22MM MEDIUM PERFORATED CONFORMERS, 23MM MEDIUM PERFORATED CONFORMERS, 20MM SMALL PVP PERFORATED PLUGS, MINI PLUG PVP PERFORATED PLUGS, MEDIUM PLUG PVP perforated plug OCULID Implantable Eyelid Weights OCULID Slim Implantable Eyelid Weights PLATINUM TAPERED WEIGHT EYELID IMPLANTS GOLD TAPERED WEIGHT EYELID IMPLANTS Gold and Platinum Tapered Weight Eyelid Implants RETILOCK, 25GA NON-VALVED CANNULAS RETILOCK, 23GA NON-VALVED CANNULAS RETILOCK, 25GA VALVED CANNULAS RETILOCK, 23GA VALVED CANNULAS REUSABLE DOUBLE DILATOR, FINE & MEDIUM TAPERS DISPOSABLE PUNCTUM DILATOR & PLUG INSERTER LACRIMAL DILATOR DISPOSABLE Disposable Punctum Dilator BOWMAN PROBE, BOWMAN PROBE SIZE 3 & 4 BOWMAN PROBE, BOWMAN PROBE SIZE 1 & 2 SIZER FOR SELF-RETAINING INTUBATION Sizer for LacriJet BOWMAN PROBE, BOWMAN PROBE SIZE 00 & 0 miLOOP SU MACKOOL HOOKS miLOOP reusable PUNCTAL GAUGES FOR READY-SET PLUGS, PUNCTAL GAUGE SET 6 GAUGE SIZES (3 INSTRUMENTS) INVITRIA INTRAVITREAL INJECTION ASSISTANT Goncalves Invitria Precivia Version I Precivia Version P Non-Sterile Precivia Version P Precivia Version I Non-Sterile Ritleng+ PVP Ritleng+ Silicone Orbital Implants Enucleation/evisceration implants ENUCLEATION/EVISCERATION DISPOSABLE SIZERS WIDE/MEDIUM COLLARETTE MONOKA, 3MM MEDIUM MONO-CRAWFORD, 3MM MEDIUM COLLARETTE BOX OF 1 WIDE/MEDIUM COLLARETTE MONOKA, 4MM WIDE MONO-CRAWFORD, 4MM WIDE COLLARETTE BOX OF 3 MONO-CRAWFORD, 3MM MEDIUM COLLARETTE BOX OF 3 MONO-CRAWFORD, 4MM PVP WIDE COLLARETTE BOX OF 1 MONO-CRAWFORD, 3MM PVP MEDIUM COLLARETTE BOX OF 3 MONO-CRAWFORD, 3MM PVP MEDIUM COLLARETTE BOX OF 1 MONO-CRAWFORD, 4MM WIDE COLLARETTE BOX OF 1 MONO-CRAWFORD, 4MM PVP WIDE COLLARETTE BOX OF 3 Merit Marquis Flow Switch SPHERE INTRODUCER Nunchaku 90 mm Nunchaku 105 mm Ptose-Up Ptose Up 3 mm Width J.M. Ruban, M.D. Ptose Up 2 mm Width J.M. Ruban, M.D. Ptosis Sling Ptosis Strip TI/HA Peg and Sleeve System Large Size Ti/HA Peg & Sleeve System TI/HA Peg and Sleeve System Titanium peg and sleeve Egg Shaped Bioceramic Orbital Implant Bioceramic orbital implants DISPOSABLE TANO POLISHER, 20GA DISPOSABLE TANO POLISHER, 25GA DISPOSABLE TANO POLISHER, 23GA Crawford Bicanaliculus Intubation Transnasal Lacrimal Stent Becker Stent Single-Use Three-Mirrors Contact Lens 3 MIRRORS CONTACT LENS ( SINGLE USE ) Tissue Expander Hemisphere 0,9ml Tissue Expander Hemisphere 0,9ml/P Tissue Expander Sphere 1ml Tissue Expander Hemisphere 1,5ml Tissue Expander Sphere 4ml Tissue Expander Hemisphere 0,4ml Tissue Expander Sphere 5ml Tissue Expander Hemisphere 2ml Tissue Expander Sphere 2ml Tissue Expander Sphere 3ml STRAIGHT LASER PROBE, 27G QUANTEL STRAIGHT LASER PROBE, 27G DORC STRAIGHT LASER PROBE, 27G ALCON/COHERENT/ZEISS/ELLEX/OS4 STRAIGHT ILLUM LASER PROBE,20G ALC/COH/ZEISS/ELLEX/OS4&19G N. FLEX CURVED LASER PROBE, 25G QUANTEL T.CURVED ILLUM LASER PROBE,23G QUANTEL & 19G NEEDLE 90 DEGREE ADJUSTABLE LASER PROBES, 23GA DORC CURVED LASER PROBE, 25G IRIDEX/B&L T.CURVED ILLUM LASER PROBE,25G IRIDEX/B&L & 19G NEEDLE FLEX CURVED LASER PROBE, 23G ALCON/COHERENT/ZEISS/ELLEX/OS4 CURVED ILLUM LASER PROBE,20G DORC & 19G NEEDLE STRAIGHT LASER PROBE, 25G QUANTEL STRAIGHT LASER PROBE, 20G DORC CURVED ILLUM LASER PROBE,20G NIDEK & 19G NEEDLE STRAIGHT ILLUM LASER PROBE,20G NIDEK & 19G NEEDLE STRAIGHT LASER PROBE, 23G QUANTEL STRAIGHT ILLUM LASER PROBE,20G IRIDEX/B&L & 19G NEEDLE STRAIGHT ILLUM LASER PROBE,27G IRIDEX/B&L & 19G NEEDLE FLEX CURVED LASER PROBE, 25G NIDEK CURVED LASER PROBE, 23G ALCON/COHERENT/ZEISS/ELLEX/OS4 90 DEGREE ADJUSTABLE LASER PROBES, 23GA NIDEK/LUMENIS NOVUS SPECTRA STRAIGHT ILLUM LASER PROBE,20G QUANTEL & 19G NEEDLE 90 Degree ADJUSTABLE LASER PROBE, 23G QUANTEL T.CURVED ILLUM LASER PROBE,23G ALC/COH/ZEISS/ELLEX/OS4&19G N. 90 DEGREE ADJUSTABLE LASER PROBES, 23GA ALCON/COHERENT/ZEISS/ELLEX/OS4 90 DEGREE ADJUSTABLE LASER PROBES, 25GA ALCON/COHERENT/ZEISS/ELLEX/OS4 STRAIGHT ILLUM LASER PROBE,27G ALC/COH/ZEISS/ELLEX/OS4&19G N. STRAIGHT ILLUM LASER PROBE,23G ALC/COH/ZEISS/ELLEX/OS4&19G N. STRAIGHT LASER PROBE, 20G IRIDEX/B&L T.CURVED ILLUM LASER PROBE,25G DORC & 19G NEEDLE T.CURVED ILLUM LASER PROBE,25G NIDEK & 19G NEEDLE STRAIGHT LASER PROBE, 20G ALCON/COHERENT/ZEISS/ELLEX/OS4 FLEX CURVED LASER PROBE, 23G QUANTEL CURVED ILLUM LASER PROBE,20G IRIDEX/B&L & 19G NEEDLE CURVED LASER PROBE, 20G NIDEK T.CURVED ILLUM LASER PROBE,23G IRIDEX/B&L & 19G NEEDLE FLEX CURVED LASER PROBE, 23G IRIDEX/B&L STRAIGHT ILLUM LASER PROBE,23G NIDEK & 19G NEEDLE 90 DEGREE ADJUSTABLE LASER PROBES, 25GA DORC STRAIGHT LASER PROBE, 27G IRIDEX/B&L STRAIGHT LASER PROBE, 23G ALCON/COHERENT/ZEISS/ELLEX/OS4 CURVED LASER PROBE, 25G QUANTEL CURVED LASER PROBE, 23G IRIDEX/B&L STRAIGHT LASER PROBE, 27G NIDEK STRAIGHT LASER PROBE, 25G ALCON/COHERENT/ZEISS/ELLEX/OS4 STRAIGHT ILLUM LASER PROBE,25G ALC/COH/ZEISS/ELLEX/OS4&19G N. STRAIGHT ILLUM LASER PROBE,27G QUANTEL & 19G NEEDLE CURVED LASER PROBE, 23G DORC STRAIGHT ILLUM LASER PROBE,25G NIDEK & 19G NEEDLE STRAIGHT LASER PROBE, 23G NIDEK STRAIGHT LASER PROBE, 25G DORC STRAIGHT ILLUM LASER PROBE,25G QUANTEL & 19G NEEDLE CURVED LASER PROBE, 23G NIDEK STRAIGHT ILLUM LASER PROBE,27G DORC & 19G NEEDLE STRAIGHT LASER PROBE, 23G DORC CURVED LASER PROBE, 23G QUANTEL CURVED LASER PROBE, 25G ALCON/COHERENT/ZEISS/ELLEX/OS4 FLEX CURVED LASER PROBE, 25G IRIDEX/B&L 90 DEGREE ADJUSTABLE LASER PROBE, 23G IRIDEX/B&L CURVED ILLUM LASER PROBE,20G QUANTEL & 19G NEEDLE FLEX CURVED LASER PROBE, 23G DORC STRAIGHT LASER PROBE, 25G NIDEK CURVED LASER PROBE, 20G DORC STRAIGHT ILLUM LASER PROBE,23G DORC & 19G NEEDLE T.CURVED ILLUM LASER PROBE,23G DORC & 19G NEEDLE STRAIGHT LASER PROBE, 20G QUANTEL STRAIGHT LASER PROBE, 25G IRIDEX/B&L FLEX CURVED LASER PROBE, 23G NIDEK CURVED LASER PROBE, 20G IRIDEX/B&L STRAIGHT ILLUM LASER PROBE,25G DORC & 19G NEEDLE T.CURVED ILLUM LASER PROBE,23G NIDEK & 19G NEEDLE STRAIGHT ILLUM LASER PROBE,25G IRIDEX/B&L & 19G NEEDLE T.CURVED ILLUM LASER PROBE,25G QUANTEL & 19G NEEDLE STRAIGHT LASER PROBE, 20G NIDEK STRAIGHT ILLUM LASER PROBE,23G QUANTEL & 19G NEEDLE STRAIGHT ILLUM LASER PROBE,27G NIDEK & 19G NEEDLE STRAIGHT LASER PROBE, 23G IRIDEX/B&L STRAIGHT ILLUM LASER PROBE,23G IRIDEX/B&L & 19G NEEDLE CURVED LASER PROBE, 20G ALCON/COHERENT/ZEISS/ELLEX/OS4 T.CURVED ILLUM LASER PROBE,25G ALC/COH/ZEISS/ELLEX/OS4&19G N. CURVED LASER PROBE, 25G DORC STRAIGHT ILLUM LASER PROBE,20G DORC & 19G NEEDLE CURVED LASER PROBE, 20G QUANTEL 90 DEGREE ADJUSTABLE LASER PROBES, 25GA IRIDEX/B&L CURVED LASER PROBE, 25G NIDEK FLEX CURVED LASER PROBE, 25G ALCON/COHERENT/ZEISS/ELLEX/OS4 90 DEGREE ADJUSTABLE LASER PROBES, 25GA QUANTEL CURVED ILLUM LASER PROBE,20G ALC/COH/ZEISS/ELLEX/OS4&19G N. FLEX CURVED LASER PROBE, 25G DORC 90 DEGREE ADJUSTABLE LASER PROBES, 25GA NIDEK/LUMENIS NOVUS SPECTRA FIBER OPTIC CONNECTOR BAUSCH & LOMB STELLARIS® FCI Directional laser probes, 23G, 25G, Compatible with Alcon® / Coherent / Zeiss / Ellex / OS4® / Lightmed FCI Directional Extendable laser probes, 23G, 25G, Compatible with Nidek Thread FCI Directional laser probes, 23G, 25G, Compatible with Iridex / Bausch+Lomb™ FCI Directional laser probes, 23G, 25G, Compatible with Dorc DORC Revolver Illumination Adapter FIBER OPTIC CONNECTOR ZEISS VISALIS FIBER OPTIC CONNECTOR ALCON-ACCURUS® AND CONSTELLATION® FCI Directional laser probes, 23G, 25G, Compatible with Nidek Thread FCI Directional Extendable laser probes, 23G, 25G, Compatible with Iridex / Bausch+Lomb™ FIBER OPTIC CONNECTOR COMPATIBLE WITH DORC FCI Directional Extendable laser probes, 23G, 25G, Compatible with Quantel Supra® / Vitra® FCI Directional laser probes, 23G, 25G, Compatible with Quantel Supra® / Vitra® FCI Directional Extendable laser probes, 23G, 25G, Compatible with Alcon® / Coherent / Zeiss / Ellex / OS4® / Lightmed FCI Directional Extendable laser probes, 23G, 25G, Compatible with DORC READY-SET PLUGS, SLANTED COLLARETTE PLUGS 0.8MM SMALL READY-SET PLUGS, SLIM PLUGS 0.4MM SLIM MINI READY-SET PLUGS, SLANTED COLLARETTE PLUGS 0.9MM MEDIUM READY-SET PLUGS, SLIM PLUGS 0.5MM SLIM PETITE READY-SET PLUGS, SLANTED COLLARETTE PLUGS 0.6MM MICRO READY-SET PLUGS, SLANTED COLLARETTE PLUGS 1MM LARGE READY-SET PLUGS, SLANTED COLLARETTE PLUGS 0.7MM MINI PRELOADED PUNCTAL PLUG (MINI US) - J.A. BERNARD TearSaver® – 0.7 mm 2/box TearSaver® – 0.6 mm 2/box PRELOADED PUNCTAL PLUG (EXTRA SMALL) - J.A. BERNARD PRELOADED PUNCTAL PLUG (SMALL) - J.A. BERNARD TearSaver® – 0.4 mm 2/box TearSaver® – 0.8 mm 2/box PRELOADED PUNCTAL PLUG STRAIGHT COLLARETTE (LARGE) PRELOADED PUNCTAL PLUG (MINI) - J.A. BERNARD PRELOADED PUNCTAL PLUG (REGULAR) - J.A. BERNARD PRELOADED PUNCTAL PLUG (LARGE) - J.A. BERNARD TearSaver® – 0.5 mm 2/box PRELOADED PUNCTAL PLUG STRAIGHT COLLARETTE (SMALL) CRAWFORD Crawford Probe Disposable Sizers for Self-Retaining Stents RITLENG PROBE Ritleng Bicanaliculus Intubation SELF-THREADING MONOKA, 4MM WIDE SELF-THREADING MONOKA, 4MM WIDE PVP SELF-THREADING MONOKA, 3MM MEDIUM Ritleng bicanalicular intubation Watzke Sleeve Spreading Forceps ENDONASAL FORCEPS DISPOSABLE VITREORETINAL INSTRUMENTS, 25GA SERRATED FORCEPS DISPOSABLE VITREORETINAL INSTRUMENTS, 25GA END-GRASPING FORCEPS DISPOSABLE VITREORETINAL INSTRUMENTS, 25GA ECKARDT (MACULORHEXIS) FORCEPS DISPOSABLE VITREORETINAL INSTRUMENTS, 23GA SERRATED FORCEPS DISPOSABLE VITREORETINAL INSTRUMENTS, 25GA TANO FORCEPS DISPOSABLE VITREORETINAL INSTRUMENTS, 23GA ECKARDT (MACULORHEXIS) FORCEPS DISPOSABLE VITREORETINAL INSTRUMENTS, 23GA TANO FORCEPS DISPOSABLE VITREORETINAL INSTRUMENTS, 23GA END-GRASPING FORCEPS Diamonized End-Gripping Vitreoretinal Forceps 25 GA Eckardt End-Gripping Forceps 20 GA PICK Vitreoretinal Forceps 25 GA Tano Assymmetrical End-Gripping Forceps 23 GA Vitreoretinal End-Gripping Forceps with Serrated Jaws 20 GA Flushing Adaptor (for vitreoretinal forceps/tips) ILM Vitreoretinal End-Gripping Forceps 20 GA Foreign Body Forceps 17 GA PICK Vitreoretinal Forceps 20 GA PICK Vitreoretinal Forceps 23 GA ILM Vitreoretinal End-Gripping Forceps 23 GA Angled Horizontal Subretinal Gripping Forceps 3 mm Tip 20 GA Diamonized End-Gripping Vitreoretinal Forceps 20 GA Eckardt End-Gripping Forceps 23 GA Eckardt End-Gripping Forceps 25 GA Tano Assymmetrical End-Gripping Forceps 25 GA Diamonized End-Gripping Vitreoretinal Forceps 23 GA Angled Horizontal Diamonized Gripping Forceps 20 GA Tano Assymmetrical End-Gripping Forceps 20 GA Forceps FCI Prolong Plug EZYPOR Retinal Tire Eptfe Retinal implants ePTFE SPONGE 3 mm ePTFE DUCOURNAU ® BAND 2 x 7 mm 4 x 3 mm ePTFE SPONGE (CHAUVAUD) ePTFE BAND 2.1 x 5.5 mm ePTFE SPONGE 2 x 5 mm ePTFE SPONGE 3 x 5 mm ePTFE HALF-SPONGE 2.5 x 7.5 mm 9 mm ePTFE STRIP (DESIGNED BY O. LEQUOY) ePTFE SPONGE 5 mm ePTFE SPONGE 4 mm ePTFE DUCOURNAU ® BAND 2.5 x 5.5 mm Membrane Pick 23 GA Membrane Pick 25 GA Ocular Shield DISPOSABLE VITREORETINAL INSTRUMENTS, 23GA HORIZONTAL SCISSORS DISPOSABLE VITREORETINAL INSTRUMENTS, 25GA HORIZONTAL SCISSORS DISPOSABLE VITREORETINAL INSTRUMENTS, 25GA VERTICAL SCISSORS DISPOSABLE VITREORETINAL INSTRUMENTS, 23GA VERTICAL SCISSORS Curved Vitreoretinal Scissors 25 GA ANGLED 70 Degree VERTICAL VITREORETINAL SCISSORS 23 GA Curved Vitreoretinal Scissors 20 GA ANGLED 45 Degree VERTICAL VITREORETINAL SCISSORS 25 GA Straight Vitreoretinal Scissors with Rounded Blades 20 GA Curved Vitreoretinal Scissors 23 GA ANGLED 70 Degree VERTICAL VITREORETINAL SCISSORS 20GA ANGLED HORIZONTAL VITREORETINAL 55 Degree SCISSORS 1.7mm Blades 20 GA Claus Lucke Vertical Retinotomy Scissors 20 GA ANGLED 45 Degree HORIZONTAL VITREORETINAL SCISSORS 20 GA INFANT BIKA MINI MONOKA BIKA Bika for DCR Lacrimal Intubation Sets SELF-RETAINING SET II (SRS II), 25MM SELF-RETAINING SET II (SRS II), 30MM SELF-RETAINING SET II (SRS II), 35MM Retinal Strip Retinal Sleeve Retinal Sponge Retinal Band Retinal bands & strips Retinal Tire (Type 276) BAND FOR REINFORCING SCLERA AT THE BACK OF THE EYE OPTHACATH, 2MM AND 3MM UNILATERAL KIT 1X3MM BALLOON CATHETER & DISPOSABLE INFLATION DEVICE OPTHACATH, 2MM AND 3MM BILATERAL KIT 2X2MM BALLOON CATHETER & DISPOSABLE INFLATION DEVICE OPTHACATH, 2MM AND 3MM BILATERAL KIT 2X3MM BALLOON CATHETER & DISPOSABLE INFLATION DEVICE OPTHACATH, 2MM AND 3MM UNILATERAL KIT 1X2MM BALLOON CATHETER & DISPOSABLE INFLATION DEVICE MASTERKA Single Use Backflush Passive & Active Aspiration DISPOSABLE BACKFLUSH HANDPIECES, 23GA BRUSH TIP DISPOSABLE CANNULAS, 20GA DUAL BORE TIP REUSABLE BACKFLUSH HANDLES, ACTIVE HANDLE DISPOSABLE BACKFLUSH HANDPIECES, 20GA DIAMOND DUSTED SOFT TIP DISPOSABLE BACKFLUSH HANDPIECES, 25GA DIAMOND DUSTED SOFT TIP DISPOSABLE CANNULAS, 25GA BLUNT TIP DISPOSABLE BACKFLUSH HANDPIECES, 20GA BLUNT TIP DISPOSABLE CANNULAS, 20GA BLUNT TIP DISPOSABLE BACKFLUSH HANDPIECES, 23GA SOFT TIP DISPOSABLE CANNULAS, 23GA SUBRETINAL TIP DISPOSABLE BACKFLUSH HANDPIECES, 25GA SOFT TIP DISPOSABLE CANNULAS, 20GA BRUSH TIP DISPOSABLE CANNULAS, 25GA SOFT TIP DISPOSABLE BACKFLUSH HANDPIECES, 23GA BLUNT TIP DISPOSABLE CANNULAS, 25GA SUBRETINAL TIP DISPOSABLE BACKFLUSH HANDPIECES, 23GA DIAMOND DUSTED SOFT TIP DISPOSABLE CANNULAS, 23GA BRUSH TIP DISPOSABLE BACKFLUSH HANDPIECES, 25GA BRUSH TIP DISPOSABLE BACKFLUSH HANDPIECES, 20GA SOFT TIP DISPOSABLE BACKFLUSH HANDPIECES, 27GA BLUNT TIP DISPOSABLE CANNULAS, 23GA DUAL BORE TIP DISPOSABLE BACKFLUSH HANDPIECES, 25GA BLUNT TIP DISPOSABLE CANNULAS, 23GA BLUNT TIP DISPOSABLE CANNULAS, 25GA DUAL BORE TIP DISPOSABLE CANNULAS, 25GA BRUSH TIP DISPOSABLE CANNULAS, 20GA SOFT TIP DISPOSABLE CANNULAS, 23GA SOFT TIP DISPOSABLE BACKFLUSH HANDPIECES, 20GA BRUSH TIP REUSABLE BACKFLUSH HANDLES, PASSIVE HANDLE Reusable Backflush Passive & Active Aspiration Replacement Reservoirs for Backflush STOPLOSS, 3.5MM 9MM STOPLOSS, 3.5MM 10MM STOPLOSS, 3.5MM 21MM STOPLOSS, 3.5MM 15MM STOPLOSS, 3.5MM 16MM STOPLOSS, 3.5MM 14MM STOPLOSS, 3.5MM 18MM STOPLOSS, 4MM 14MM STOPLOSS, 3.5MM 19MM STOPLOSS JONES TUBE INTRODUCER SET STOPLOSS, 4MM 15MM STOPLOSS, 3.5MM 12MM STOPLOSS, 3.5MM 22MM STOPLOSS, 3.5MM 17MM STOPLOSS, 3.5MM 11MM STOPLOSS, 4MM 16MM STOPLOSS, 4MM 13MM STOPLOSS, 3.5MM 13MM STOPLOSS, 4MM 22MM STOPLOSS, 4MM 19MM STOPLOSS, 4MM 21MM STOPLOSS, 4MM 9MM STOPLOSS, 4MM 18MM STOPLOSS, 4MM 17MM STOPLOSS, 4MM 11MM STOPLOSS, 4MM 10MM STOPLOSS JONES TUBE REMOVAL TOOL STOPLOSS, 4MM 12MM STOPLOSS, 3.5MM 20MM STOPLOSS, 4MM 20MM Mesh wrapped bioceramic orbital imp Bige II Self-Retaining Bicanaliculus Intubation Set II LacriJet Painless Plug Snug Plug disposable infusion cannula surgical knife Disposable vitrectomy lens DISPOSABLE SIZERS

Establishment Types

Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Foreign Private Label Distributor Complaint File Establishment per 21 CFR 820.198