BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    INSTRUMENTARIUM SURGICAL CORP., INC.

    Reg #: 9615857 · FEI: 3002409980 · Expires 2026
    View on FDA
    Products
    76
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    76

    Registration Details

    Registration Name
    INSTRUMENTARIUM SURGICAL CORP., INC.
    Registration Number
    9615857
    FEI Number
    3002409980
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1273 Rue Saint-Louis
    City
    TERREBONNE Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K182812

    Owner / Operator

    Firm Name
    INSTRUMENTARIUM SURGICAL CORP., INC.
    Operator Number
    9041885
    Address
    1273 RUE SAINT-LOUIS, --
    City
    TERREBONNE
    State
    Quebec
    Postal Code
    J6W 1K6
    Country
    CA
    Correspondent
    JEAN-PAUL - DAVID

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Instrument, Ent Manual Surgical LRC
    Trocar, Ent KTE
    Punch, Surgical LRY
    Snare, Ear JZD
    Tap, Bone HWX
    Snare, Nasal KBE
    Rongeur, Lachrymal Sac HNG
    Probe, Ent KAK
    Stripper, Vein, Reusable GAI
    Forceps, Ent KAE
    Rasp, Ear JYY
    Hook, Surgical, General & Plastic Surgery GDG
    Ring, Ophthalmic (Flieringa) HNH
    Elevator, Ent KAD
    Cannula, Ophthalmic HMX
    Knife, Surgical EMF
    Holder, Speculum, Ent KAG
    Probe, Lachrymal HNL
    Retractor, Self-Retaining FFO
    Retractor, Ent KAL
    Knife, Nasal KAS
    Cannula, Surgical, General & Plastic Surgery GEA
    Hook, Ophthalmic HNQ
    Camera, Cine, Endoscopic, Without Audio FWL
    Curette, Ophthalmic HNZ
    Instrument, Cutting, Orthopedic HTZ
    Saw, Nasal KBC
    Compressor, Orbital HOA
    Cannula, Sinus KAM
    Punch, Nasal KAY
    Knife, Ophthalmic HNN
    Instrument, Manual, Surgical, General Use MDM
    Trephine, Sinus KBF
    Device, Percutaneous, Biopsy MJG
    Hook, Microsurgical Ear JYL
    Mallet HXL
    Burr, Corneal, Manual HOF
    Dissector, Surgical, General & Plastic Surgery GDI
    Gouge, Nasal, Ent KAQ
    Elevator, Surgical, General & Plastic Surgery GEG
    Snare, Surgical GAE
    Holder, Needle, Gastroenterologic FHQ
    Mirror, Ent KAI
    Knife, Ent KTG
    Cannula, Ear JYC
    Speculum, Ent EPY
    Tray, Surgical, Instrument FSM
    Trephine, Manual, Ophthalmic HRH
    Scissors, Ophthalmic HNF
    Needle, Suturing, Reusable GDL
    Curette, Nasal KAP
    Chisel, Surgical, Manual FZO
    Spatula, Ophthalmic HND
    Needle, Aspiration And Injection, Reusable GDM
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Retractor, Ophthalmic HNI
    Curette, Surgical, General Use FZS
    Osteotome HWM
    Instrument, Manual, General Obstetric-Gynecologic KOH
    Punch, Ent KTF
    Rongeur, Mastoid JZA
    Tube, Ear Suction JZF
    Knife, Laryngeal JZY
    Scissors, General, Surgical LRW
    Specula, Ophthalmic HNC
    Caliper, Ophthalmic HOE
    Scissors, Ear JZB
    Punch, Corneo-Scleral HNJ
    Scissors, Nasal KBD
    Rongeur, Nasal KBB
    Rasp, Surgical, General & Plastic Surgery GAC
    Forceps, Ophthalmic HNR
    Applicator, Ent KCJ
    Retractor GAD
    Forceps, General & Plastic Surgery GEN
    Curette, Ear JYG

    Proprietary Names

    INSTRUMENTARIUM instrumentarium INSTRUMENTARIUM SURGICAL CORP. INC. Instrumentarium HEBU

    Establishment Types

    Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device