BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INTERNATIONAL STERILIZATION LABORATORY, LLC

    Reg #: 1061927 · FEI: 3000203000 · Expires 2026
    View on FDA
    Products
    105
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    105

    Registration Details

    Registration Name
    INTERNATIONAL STERILIZATION LABORATORY, LLC
    Registration Number
    1061927
    FEI Number
    3000203000
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    217 SAMPEY RD.
    City
    GROVELAND
    State
    FL
    ZIP
    34736
    Country
    US

    Owner / Operator

    Firm Name
    INTERNATIONAL STERILIZATION LABORATORY, LLC
    Operator Number
    9051636
    Address
    217 SAMPEY RD., --
    City
    Groveland
    State
    FL
    Postal Code
    34736
    Country
    US
    Correspondent
    Steve - Walter

    Products

    Device Name Product Code
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Washer, Bolt Nut HTN
    Electrode, Pacemaker, Temporary LDF
    Screw, Fixation, Bone HWC
    Introducer, Catheter DYB
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Staple, Fixation, Bone JDR
    Unit, Cautery, Thermal, Battery-Powered HQP
    Plate, Fixation, Bone HRS
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Pin, Fixation, Smooth HTY
    Permanent Pacemaker Electrode DTB
    Trocar DRC
    Suture, Nonabsorbable, Silk GAP
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Lumbar Puncture Tray (Adult & Pediatric) PWY
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Bone Mill LYS
    Dressing, Wound, Drug FRO
    Laparoscope, General & Plastic Surgery GCJ
    Arthroscope HRX
    Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt PTS
    Monitor, Ultrasonic, Fetal KNG
    Clamp, Vascular DXC
    Light, Surgical, Instrument FSQ
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Illuminator, Non-Remote FTF
    Cannula, Surgical, General & Plastic Surgery GEA
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Custom Anesthesia Tray OGD
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    System, Dialysate Delivery, Central Multiple Patient FKQ
    Cable, Electrode IKD
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Stimulator, Nerve ETN
    Negative Pressure Wound Therapy Powered Suction Pump OMP
    Kit, Surgical Instrument, Disposable KDD
    Sleeve, Limb, Compressible JOW
    Catheter, Flow Directed DYG
    Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) KNF
    Electrode, Electrosurgical JOS
    Passer HWQ
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Pacemaker Lead Adaptor DTD
    Stylet, Tracheal Tube BSR
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Accessories, Arthroscopic NBH
    Tray, Surgical, Instrument FSM
    Set, I.V. Fluid Transfer LHI
    Cement, Bone, Vertebroplasty NDN
    Hemostatic Metal Clip For The Gi Tract PKL
    Syringe, Piston FMF
    Spinal Anesthesia Kit OFU
    Apparatus, Electrosurgical HAM
    Endoscopic Cytology Brush FDX
    Enteral Syringes With Enteral Specific Connectors PNR
    Apparatus, Traction, Non-Powered HST
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
    Punch, Corneo-Scleral HNJ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Instrument, Biopsy KNW
    Endoscopic Grasping/Cutting Instrument, Non-Powered OCZ
    Retention Device, Suture KGS
    Suture, Nonabsorbable, Synthetic, Polyester GAS
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Tape And Bandage, Adhesive KGX
    Transducer, Ultrasonic, Diagnostic ITX
    Forceps, Biopsy, Electric KGE
    Anesthesia Conduction Kit CAZ
    Orthopedic Manual Surgical Instrument LXH
    Holder, Needle; Orthopedic HXK
    Forceps, Biopsy, Non-Electric FCL
    Spinal Epidural Anesthesia Kit OFT
    Epidural Anesthesia Kit OGE
    Needle, Aspiration And Injection, Disposable GAA
    Snare, Non-Electrical FGX
    Catheter, Percutaneous DQY
    Dispenser, Liquid Medication KYX
    Suture Removal Kit MCZ
    Staple, Absorbable MNU
    Instrument, Manual, Surgical, General Use MDM
    Bit, Drill HTW
    Brush, Biopsy, General & Plastic Surgery GEE
    Cannula, Ophthalmic HMX
    Discography Kit OIL
    Allergen And Vaccine Delivery Needles SCL
    Dressing, Wound, Occlusive NAD
    Spinal Channeling Instrument, Vertebroplasty OCJ
    Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact QEH
    Dressing, Wound, Hydrophilic NAC
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Screwdriver HXX
    Perforator, Ear-Lobe JYS
    Guide, Surgical, Instrument FZX
    Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene NBY
    Forceps, Biopsy, Bronchoscope (Non-Rigid) BWH
    Electrocautery, Gynecologic (And Accessories) HGI
    Catheter, Intravascular, Diagnostic DQO
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Nerve Block Tray OGJ
    Container, I.V. KPE
    Instrument, Ent Manual Surgical LRC

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Device in the United States for Export Only