BEUDAMED
    FDA Registration Active 🇬🇹 Guatemala

    Ortho and Surgical Products Enterprises S.A.

    Reg #: 3010452421 · FEI: 3010452421 · Expires 2026
    View on FDA
    Products
    75
    Proprietary Names
    72
    Establishment Types
    2
    Classifications
    75

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    Registration Details

    Registration Name
    Ortho and Surgical Products Enterprises S.A.
    Registration Number
    3010452421
    FEI Number
    3010452421
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    KM 20.5 Carretera a Villa Canales, Zona 3 Finca Morancito,
    City
    Villa Canales Guatemala
    Country
    GT

    Regulatory Submissions

    510(k) Number
    K820442

    Owner / Operator

    Firm Name
    DEROYAL INDUSTRIES, INC.
    Operator Number
    1044833
    Address
    200 DEBUSK LN., --
    City
    Powell
    State
    TN
    Postal Code
    37849
    Country
    US
    Correspondent
    Elizabeth Reed

    US Agent

    Business Name
    DeRoyal Industries, Inc.
    Contact Name
    Elizabeth Reed
    Address
    200 Debusk Ln
    City
    Powell
    State
    TN
    ZIP
    37849
    Country
    US
    Email
    [email protected]
    Phone
    865 3621256

    Products

    Device Name Product Code
    Burn Kit Without Drug OJJ
    Marker, Skin FZZ
    Bedding, Disposable, Medical KME
    Forceps, General & Plastic Surgery GEN
    Drape, Surgical, Exempt PUI
    Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ
    Gauze/Sponge, Internal, X-Ray Detectable GDY
    Tubes, Gastrointestinal (And Accessories) KNT
    Device, Fixation, Tracheal Tube CBH
    Tourniquet, Nonpneumatic GAX
    General Surgery Tray LRO
    Support, Patient Position CCX
    Applicator, Absorbent Tipped, Sterile KXG
    Instrument, Surgical, Disposable KDC
    Dissector, Surgical, General & Plastic Surgery GDI
    Pad, Neonatal Eye FOK
    Suture, Absorbable, Natural GAL
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile GAQ
    Suture, Nonabsorbable, Synthetic, Polypropylene GAW
    Suture, Nonabsorbable, Synthetic, Polyamide GAR
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Suture, Nonabsorbable, Silk GAP
    Splint, Traction HSP
    Gauze/Sponge, Internal EFQ
    Laparoscope, General & Plastic Surgery GCJ
    Operating Room Accessories Table Tray FWZ
    Walker, Mechanical ITJ
    Restraint, Wheelchair, Non-Protective KID
    Dressing, Wound, Drug FRO
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Tape And Bandage, Adhesive KGX
    Bed, Ac-Powered Adjustable Hospital FNL
    Scissors, General, Surgical LRW
    Protector, Skin Pressure FMP
    Halter, Head, Traction HSS
    Dressing Change Tray OXQ
    Cover, Limb IPM
    Sheet, Burn FPY
    Hemostat HRQ
    Restraint, Protective FMQ
    Dressing, Wound, Occlusive NAD
    Device, Intravascular Catheter Securement KMK
    Kit, Surgical Instrument, Disposable KDD
    Orthosis, Cervical IQK
    Device, Transfer, Patient, Manual FMR
    Gauze / Sponge,Nonresorbable For External Use NAB
    Dressing, Wound, Hydrophilic NAC
    Aid, Transfer IKX
    Bandage, Cast ITG
    Fiber, Medical, Absorbent FRL
    Splint, Hand, And Components ILH
    Bandage, Elastic FQM
    Accessories, Traction ILZ
    Binder, Abdominal FSD
    Sling, Arm ILI
    Scissors, Medical, Disposable JOK
    Exerciser, Powered BXB
    Splint, Clavicle IQJ
    Catheter, Irrigation GBX
    Container, Specimen, Non-Sterile NNI
    Catheter, Peritoneal GBW
    Orthosis, Limb Brace IQI
    Joint, Shoulder, External Limb Component IQQ
    Joint, Knee, External Brace ITQ
    Tubing, Noninvasive GAZ
    Crutch IPR
    Tube, Levine FRQ
    Tray, Surgical LRP
    Joint, Ankle, External Brace ITW
    Syringe, Piston FMF
    Instrument, Manual, Surgical, General Use MDM
    Component, Traction, Non-Invasive KQZ
    Cotton, Roll EFN
    Orthosis, Lumbo-Sacral IPY

    Proprietary Names

    Burn Kit without Drug - DeRoyal Marker, Skin - DeRoyal Bedding Disposable, Medical - DeRoyal Forceps, General & Plastic Surgery - DeRoyal Drape, Surgical, Exempt - DeRoyal Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene - DeRoyal Gauze/Sponge, Internal, X-Ray Detectable - DeRoyal Tubes, Gastrointestinal (and Accessories) - DeRoyal Device, Fixation, Tracheal Tube - DeRoyal Tourniquet, Nonpneumatic - DeRoyal General Surgery Tray (Kit) - DeRoyal General Surgery Tray - DeRoyal Support, Patient Position - DeRoyal Applicator, Absorbent Tipped, Sterile - DeRoyal Instrument, Surgical, Disposable - DeRoyal Dissector, Surgical, General & Plastic Surgery - DeRoyal Pad, Neonatal Eye - DeRoyal Suture, Nonabsorbable, Silk - DeRoyal Splint, Traction - DeRoyal Stax Gauze/Sponge, Internal - DeRoyal Laparoscope, General & Plastic Surgery - DeRoyal Accessories, Operating-Room, Table (Kit) - DeRoyal Walker, Mechanical - DeRoyal Restraint, Wheelchair, Non-Protective - DeRoyal Dressing, Wound, Drug - DeRoyal Applicator, Absorbent Tipped, Non-Sterile - DeRoyal Tape and Bandage, Adhesive - DeRoyal Bed, Ac-Powered Adjustable Hospital - DeRoyal Scissors, General, Surgical - DeRoyal Protector, Skin Pressure - DeRoyal Halter, Head, Traction - DeRoyal Dressing Change Tray - DeRoyal Cover, Limb - DeRoyal Sheet, Burn - DeRoyal Hemostat - DeRoyal Restraint, Protective - DeRoyal Dressing, Wound, Occlusive - DeRoyal Device, Intravascular Catheter Securement - DeRoyal Kit, Surgical Instrument, Disposable - DeRoyal Orthosis, Cervical - DeRoyal Device, Transfer, Patient, Manual - DeRoyal Gauze/Sponge, Nonresorbable for External Use - DeRoyal Dressing, Wound, Hydrophilic - DeRoyal Aid, Transfer - DeRoyal Bandage, Cast - DeRoyal Fiber, Medical, Absorbent - DeRoyal Splint, Hand, and Components - DeRoyal WRIST Bandage, Elastic - DeRoyal Accessories, Traction - DeRoyal Binder, Abdominal - DeRoyal Sling, Arm - DeRoyal Scissors, Medical, Disposable - DeRoyal Exercise, Powered - DeRoyal Splint, Clavicle - DeRoyal Catheter, Irrigation - DeRoyal Container, Specimen, Non-Sterile - DeRoyal Catheter, Peritoneal - DeRoyal Orthosis, Limb Brace - DeRoyal Joint, Shoulder, External Limb Component - DeRoyal Joint, Knee, External Brace - DeRoyal Tubing, Noninvasive - DeRoyal Crutch - DeRoyal Tube, Levine - DeRoyal Tray, Surgical - DeRoyal Joint, Ankle, External Brace - DeRoyal Syringe, Piston - DeRoyal Instrument, Manual, Surgical, General Use - DeRoyal Component, Traction, Non-Invasive - DeRoyal Cotton, Roll - DeRoyal Orthosis, Lumbo-Sacral - DeRoyal

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device