BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STERI-TEK

    Reg #: 3012448339 · FEI: 3012448339 · Expires 2026
    View on FDA
    Products
    38
    Proprietary Names
    40
    Establishment Types
    1
    Classifications
    38

    Registration Details

    Registration Name
    STERI-TEK
    Registration Number
    3012448339
    FEI Number
    3012448339
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    48225 Lakeview Blvd
    City
    Fremont
    State
    CA
    ZIP
    94538
    Country
    US

    Owner / Operator

    Firm Name
    Steri-Tek
    Operator Number
    10051493
    Address
    48225 Lakeview Blvd.
    City
    Fremont
    State
    CA
    Postal Code
    94538
    Country
    US
    Correspondent
    Larry Nichols Nichols

    Products

    Device Name Product Code
    Mesh, Surgical FTM
    Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon OWY
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Needle, Aspiration And Injection, Disposable GAA
    Tape And Bandage, Adhesive KGX
    Absorbable Synthetic Wound Dressing QSZ
    Polymer, Ear, Nose And Throat, Synthetic, Absorbable NHB
    Vapocoolant Device MLY
    Wire, Guide, Catheter, Exempt PTL
    Cannula, Injection FGY
    Filler, Bone Void, Calcium Compound MQV
    Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP
    Catheter, Percutaneous DQY
    Wound Dressing With Animal-Derived Material(S) KGN
    Magnetic Compression Anastomosis System SAH
    Catheter, Nasopharyngeal ENW
    Container, Specimen Mailer And Storage, Non-Sterile NNK
    Bronchoscope (Flexible Or Rigid) EOQ
    Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures PUM
    Instruments, Surgical, Cardiovascular DWS
    Passer HWQ
    Catheter, Continuous Flush KRA
    Mesh, Surgical, Collagen, Staple Line Reinforcement OXE
    Device, Vascular, For Promoting Embolization KRD
    Forceps, Biopsy, Non-Electric FCL
    Splint, Intranasal Septal LYA
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Hook, Ophthalmic HNQ
    Integrated Continuous Glucose Monitoring System, Factory Calibrated QBJ
    Drug-Eluting Sinus Stent OWO
    Dura Substitute GXQ
    Staple, Removable (Skin) GDT
    Needle, Acupuncture, Single Use MQX
    Dressing, Wound, Drug FRO
    Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management QDK
    Syringe, Piston FMF
    Knife, Ophthalmic HNN
    Device, Hemostasis, Vascular MGB

    Proprietary Names

    Biodesign Staple Line Reinforcement Finesse™ Injectable PTA Balloon Dilatation Catheter Donaldson Decompression Needle (DDN) Band Aid Brand microMend PRO microMend BackVive Restrata Latera Absorbable Nasal Implant and Delivery Device Speed Torque EntreVu Cannula AlloFuse Gel, AlloFuse Putty SSPC Delivery Catheter Flowable Wound Matrix Flexagon SFM Plus OTOLoc System (FlesFie Universal Laparoscopic Delivery) AccuLif TL8-12 Implant Tasso-M20 Blowfish® Transbronchial Micro-Infusion Device (Bronchoscope, flexible or rigid) CPS Locator 3D Delivery Catheter Sentinel CPS Helix Locking Tool Revolution Suture Passer Bullfrog® Micro-Infusion Device (Catheter, continuous flush) IMPEDE Embolization Plug, 10mm IMPEDE Embolization Plug, 5mm IMPEDE Embolization Plug, 7mm SSPC NXT Delivery Catheter AlloFuse Plus Paste, AlloFuse Plus Putty NanoFUSE Bioactive Matrix; Bio V BP Bioactive Glass with DBM Putty LUKE BX Biopsy Forceps NanoFUSE Bioactive Strip Tasso-M20; Tasso+ miLOOP Dexcom G6 CGM System Propel Cerafix Flexagon SFM System Backpack AF Osteoinductive Bone Graft Dexcom G6 Glucose Program CGM System Ziplyft Blepharoplasty kit

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)