BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STEPHENS INSTRUMENTS, INC

    Reg #: 1045379 · FEI: 1045379 · Expires 2026
    View on FDA
    Products
    52
    Proprietary Names
    55
    Establishment Types
    6
    Classifications
    52

    Registration Details

    Registration Name
    STEPHENS INSTRUMENTS, INC
    Registration Number
    1045379
    FEI Number
    1045379
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2500 Sandersville Rd
    City
    LEXINGTON
    State
    KY
    ZIP
    40511
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140352

    Owner / Operator

    Firm Name
    STEPHENS INSTRUMENTS, INC.
    Operator Number
    1045379
    Address
    2500 SANDERSVILLE RD., --
    City
    Lexington
    State
    KY
    Postal Code
    40511
    Country
    US

    Products

    Device Name Product Code
    Spatula, Ophthalmic HND
    Dissector, Surgical, General & Plastic Surgery GDI
    Trypan Blue LGY
    Cystotome HNY
    Plug, Punctum LZU
    Scissors, Ophthalmic HNF
    Holder, Needle; Orthopedic HXK
    Marker, Ocular HMR
    Instrument, Measuring, Corneal Radius HJB
    Clamp, Muscle, Ophthalmic HOB
    Retractor, Ophthalmic HNI
    Forceps, Ophthalmic HNR
    Curette, Ophthalmic HNZ
    Marker, Sclera HMQ
    Trephine, Manual, Ophthalmic HRH
    Gauge, Lens, Ophthalmic HLN
    Burr, Corneal, Manual HOF
    Handle, Scalpel GDZ
    Clamp, Eyelid, Ophthalmic HOD
    Trabeculotome HMZ
    Probe, Trabeculotomy HNK
    Cannula, Ophthalmic HMX
    Clip, Lens, Trial, Ophthalmic HPB
    Hook, Ophthalmic HNQ
    Specula, Ophthalmic HNC
    Caliper, Ophthalmic HOE
    Ruler, Nearpoint (Punctometer) HLE
    Needle, Aspiration And Injection, Reusable GDM
    Punch, Corneo-Scleral HNJ
    Ring, Ophthalmic (Flieringa) HNH
    Probe, Lachrymal HNL
    Clip, Iris Retractor HOC
    Knife, Ophthalmic HNN
    Dilator, Lachrymal HNW
    Magnifier, Hand-Held, Low-Vision HJF
    General Purpose Reagent PPM
    Lens, Maddox HKR
    Container, Specimen, Sterile FMH
    Rongeur, Lachrymal Sac HNG
    Frame, Trial, Ophthalmic HPA
    Clip, Tantalum, Ophthalmic HQW
    Set, Lens, Trial, Ophthalmic HPC
    Burr, Corneal, Battery Powered, Rust Ring Removal OHW
    Eye, Artificial, Non-Custom HQH
    Depressor, Orbital HNX
    Unit, Syringe, Air And/Or Water ECB
    Spud, Ophthalmic HNA
    Spoon, Ophthalmic HNB
    Burr, Corneal, Battery-Powered HOG
    Holder, Needle, Gastroenterologic FHQ
    Expressor HNS
    Tray, Surgical, Instrument FSM

    Proprietary Names

    Ophthalmic Spatula Dissector C-BLUE Cystotome Lacrivera Stephens Scissors Needle Holder Ocular Marker Corneal radius measurement instrument Muscle Clamp Ophthalmic Retractor Stephens Forceps Curette Sclera Marker Stephens Trephine Ophthalmic Gauge Ophthalmic Burr Scalpel Eyelid clamp Trabeculotome Ophthalmic Probe Vera90 Cannula Stephens Glass Cannula Clip Stephens Hook Stephens Speculum Caliper Ruler Aspiration Needle Scleral Punch Stephens Instruments Fixation Ring Probe, Lachrymal Xpand Stephens Microsurgical Blades Dilator Magnifier PV Iodine Maddox Stephens Corneal Viewing Chamber Lachrymal Rongeur Ophthalmic Frame Clip, Tantalum, Ophthalmic Vera180 Ophthalmic Set Corneal Burr, rust ring removal Artificial Eye Orbital Depressor Syringe Cannula Ophthalmic Spud VeraC7 Ophthalmic Spoon Corneal burr Expressor Stephens Instruments Sterilization Tray

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Reprocess Single-Use Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility