BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BUSSE HOSPITAL DISPOSABLES

    Reg #: 2433012 · FEI: 2433012 · Expires 2026
    View on FDA
    Products
    78
    Proprietary Names
    226
    Establishment Types
    5
    Classifications
    78

    Registration Details

    Registration Name
    BUSSE HOSPITAL DISPOSABLES
    Registration Number
    2433012
    FEI Number
    2433012
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    75 ARKAY DR.
    City
    HAUPPAUGE
    State
    NY
    ZIP
    11788
    Country
    US

    Regulatory Submissions

    510(k) Number
    K061394

    Owner / Operator

    Firm Name
    ROBERT BUSSE & CO., INC.
    Operator Number
    2417536
    Address
    75 ARKAY DR., --
    City
    HAUPPAUGE
    State
    NY
    Postal Code
    11788
    Country
    US

    Products

    Device Name Product Code
    Wound Dressing Kit MCY
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Apron, Protective IWO
    Curette, Uterine HCY
    Cesarean Section Tray OHM
    Instrument, Biopsy KNW
    I.V. Start Kit LRS
    Gauze / Sponge,Nonresorbable For External Use NAB
    Peripheral Catheter Insertion Kit OWL
    Arthrogram Tray OII
    Catheter, Peritoneal GBW
    Epidural Anesthesia Kit OGE
    Circumcision Tray OHG
    Anesthesia Conduction Kit CAZ
    Instrument, Surgical, Disposable KDC
    Pad, Menstrual, Unscented HHD
    Accessory, Surgical Apparel LYU
    Suture Removal Kit MCZ
    Sampler, Amniotic Fluid (Amniocentesis Tray) HIO
    Hysteroscope Accessories NWW
    Instrument, Clip Forming/Cutting HBS
    Tubing, Pressure And Accessories BYX
    Tubing, Fluid Delivery FPK
    Set, Administration, Intravascular FPA
    Nerve Block Tray OGJ
    Clamp, Umbilical HFW
    Tray, Biopsy, Without Biopsy Instruments FCH
    Punch, Surgical LRY
    Bag, Ice KYR
    Laparoscopy Kit FDE
    Gown, Isolation, Surgical FYC
    Syringe, Irrigating (Non Dental) KYZ
    Tray, Surgical, Instrument FSM
    Instrument, Manual, Surgical, General Use MDM
    Syringe, Piston FMF
    Manometer, Spinal-Fluid FMJ
    Tube, Aspirating, Flexible, Connecting BYY
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Tray, Surgical LRP
    Instrument, Surgical, Non-Powered HAO
    Intravenous Extension Tubing Set OJA
    General Surgery Tray LRO
    Label Or Tag, Sterile LYV
    Needle, Aspiration And Injection, Disposable GAA
    Trocar, Gastro-Urology FBQ
    Gastro-Urology Biopsy Kit PRV
    Orthopedic Manual Surgical Instrument LXH
    Neurological Tray OJG
    Trocar DRC
    Needle, Hypodermic, Single Lumen FMI
    Unit, Syringe, Air And/Or Water ECB
    Kit, Surgical Instrument, Disposable KDD
    Plastic Surgery And Accessories Kit FTN
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    Drape, Surgical, Exempt PUI
    Mri Disposable Kit OIM
    Pelvic Exam Kit MLT
    Mask, Surgical FXX
    Needle, Catheter GCB
    Scissors, Medical, Disposable JOK
    Tape, Measuring, Rulers And Calipers FTY
    Qualitative Chemical Reactions, Urinary Calculi (Stone) JNQ
    Eye Tray OJK
    Tray, Start/Stop (Including Contents), Dialysis FKG
    Collector, Urine, (And Accessories) For Indwelling Catheter KNX
    Wrap, Sterilization FRG
    Container, Specimen, Non-Sterile NNI
    Cover, Shoe, Operating-Room FXP
    Obstetrical Kit OKV
    Trap, Sterile Specimen BYZ
    Lumbar Puncture Tray (Adult & Pediatric) PWY
    Bag, Drainage, With Adhesive, Ostomy FON
    Container, Specimen, Sterile FMH
    Amniotome HGE
    Tracheotomy Care Kit NXA
    Forceps HTD
    Colonic Irrigation System KPL
    Cap, Surgical FYF

    Proprietary Names

    Quincke Style Spinal Needle 22g x 3 1/2" Quincke Style Long Legth Spinal Needle 22g x 5" Quincke Style Spinal Needle 25g x 3 1/2" Tuohy Epidural Needle 18g x 3 1/2" without wings Sterile Whitcare Style Spinal Needle 25g x 3 1/2" Quincke Style Spinal Needle 22g x 1 1/2" Tuohy Epidural Needle 18g x 3 1/2" with removable wings Quincke Style Spinal Needle 20g x 3 1/2" Tuohy Epidural Needle 18 x 3 1/2" with fixed wings Quincke Style Spinal Needle 18g x 3 1/2" Tuohy Epidural Needle 18g x 3 1/2" with wings Quincke Style Long Length Spinal Needle 22g x 7" Tuohy Epidural Needle 20g x 3 1/2" without wings Tuohy Epidural Needle 20g x 3 1/2" with fixed wings PLASTIC APRON 7mm Straight Curette 7mm Curved Curette 11mm Straight Curette 8mm Straight Curette 8mm Curved Curette 14mm Straight Curette 9mm Curved Curette 9mm Straight Curette 12mm Curved Curette 11mm Curved Curette 10mm Straight Curette 12mm Straight Curette 14mm Curved Curette 10mm Curved Curette J-Style Bone Marrow / Aspiration Needle - 630 I.V. Start Kit with Sepp & Tegaderm Dressing I.V. Start Kit with Tegaderm Dressing I.V. Start Kit Tracheostomy Dressing Peripheral Catheter Insertion Kit Accessories Arthrogram Tray - 957 Safety-Deluxe Arthrogram Tray - 979 Busse Paracentesis Tray Sterile Circumcision Tray EpiGlide loss of Resistance (LOR) Syringe - 10ml Plastic Loss of Resistance (LOR) Syringe with Luer Slip Tip - 596 10ml LOR Luer Lock Syringe - 5950 EpiGlide Loss of Resistance (LOR) Syringe - 10ml Plastic Loss of Resistance (LOR) Syringe with Luer Lock Tip - 595 10ml LOR Luer Slip Syringe - 5960 Pellet Insertion Tray Straight Kelly Hemostat Curved Kelly Hemostat Angled Sponge Stick - 6474 Surgical Instruments Obstetrical Kit, Box Obstetrical Kit, Pouch Absorbent Towels XXXX Large white - SMS Tri-layered Lab Coat with knit cuffs - 236 Coveralls, Extra Large, white, zipper front - 213 Fluid Resistant Gown - White, full Back Polycoated - 200 Lab Coats, Large/Extra Large, White - SMS - Tri-layered with knit cuffs - 225 Isolation Gown, Yellow - 202 Deluxe Staff Protection Kit - 198 Suture Removal Kit with Stitch Cutter Suture Removal Kit Classic Sutture Removal Tray Basic Suture Removal Kit with Floor Grade Instruments Amniocentesis Tray with 20g x 3.5 Spinal Needle Amniocentesis Tray with 20g x 3.5 Spinal Needle (includes Safety Components) Safety Deluxe Amniocentesis Tray BUSSE HOSPITAL DISPOSA Amniocentesis Tray with 20g x 3.5" Spinal Needle - 650B Busse Hysteroscopy Pack / Tray GLASS LOSS OF RESISTANCE SYRINGE BUSSE LOSS OF RESISTANCE SYRINGE Sterile Skin Staple Remover - 770 Sterile Skin Staple Remover - Stainless Steel with Plastic handles - 772 Sterile Skin Staple Remover - 716 3/8" "Y" Conncetor 6-In-1 "Y" Connector Catheter Plug with Drainage Tube Cover 6mm Straight Connector "T" Connector Sims Connector 10mm Straight Connector 8mm Straight Connector Busse Extension Sets Myelogram Tray Safety Deluxe Myelogram Tray Pump Refill Kit Nerve Block Tray Single Shot Epidural Tray with 18g x 3 1/2" - 679 Single Shot Epidural Tray - 670 Single Shot Epidural Tray with 20G x 3 1/2" - 677 Umbilical Cord Clamp I-Style Bone Marrow Aspiration Needle With T-Handle Extension Sets BUSSE HOSPITAL DISPOSABLES ICE BAG Personal Protection Gown 3 oz Bulb Syringe 1 oz Bulb Syringe 2 oz Bulb Syringe 3 oz Re-Usable Bulb Syringe 2 oz Re-Usable Bulb Syringe SAF-SHIELD Minor Procedure Pack General Purpose Instrument Tray Sterile Debridement Tray Suturing Tray Minor Laceration Tray with Instruments Facial wound Tray E.R. Laceration Tray with Safety Components Minor Laceration Tray Incision & Drainage Tray Incision & Drainage Tray with Safety Components INSTRUMENT TRAYS STERILE AND NON-STERILE Pediatric/Infant Puncture Tray with Spinal needle without manometer Pediatric/Infant Lumbar Puncture Tray with Spinal Needle and Manometer Lumbar Puncture Tray with 22g x 3 1/2" Spinal Needle and Manometer. Safety Deluxe Lumbar Puncture Tray Safety Deluxe Pediatric / Infant Lumbar Puncture Tray Busse Spinal Fluid Manometer Safety Deluxe Lumbar Puncture Tray with 22g x 3.5" Spinal Needle and Manometer - 975B Safety Pediatric/Infant Lumbar Puncture Tray with Spinal Needle and Manometer - 946B Safety Deluxe Lumbar Puncture Tray with 20g x 3.5" Spinal Needle and Manometer - 974B 6' x 1/2" Uterine Aspirating Tubing with Handle without Adaptor 6' x 3/16" ID Suction Tubing 6' x 1/4" ID Suction Tubing 6' x 1/2" Uterine Aspirating Tubing with Handle and adaptor 10' x 1/4" ID Suction Tubing 6' x 3/8" ID Uterine Aspirating Tubing with Handle and Adaptor I-Style Bone Marrow Aspiration Needle - 631 Fluid Injection Tray KITS STERILE MEDICATION LABELS Bone Marrow Biopsy / Aspiration Tray - 653B Bone Marrow Aspiration Tray - 655B Bone Marrow Biopsy / Aspiration Tray - 654 Bone Marrow Biopsy / Aspiration Tray - 653 Bone Marrow Aspiration Tray - 655 Safety Deluxe Bone Marrow Biopsy / Aspiration Tray - 985 Safety Deluxe Bone Marrow Biopsy Tray / Aspiration Tray - 988 Bone Marrow Biopsy / Aspiration Tray - 654B Bone Marrow Biopsy / Aspiration Tray - 652 Busse Carpal Tunnel Pack Bulk Packed Umbilical Cord Clamp SAF-T CUBE ALL PURPOSE BULB SYRINGE Frazier Suction Instrument Poole Suction Instrument Sigmoidoscope Suction Instrument Yankauer Suction Instrument 24" x 18" Blue Drape with 4" Fenestration with Adhesive Patch and Adhesive Strip 18" x 26" Blue / White Drape with Patch - Bulk 24" x 36" Blue / White Drape - Bulk 18" x 26" Blue / White Drape with 3" Fenestration - Bulk 18" x 26" Drape with 1.5" Fenestration - Bulk 24" x 30" Blue 4" Fenestration and Tape Strip 18" x 26" White Towel - Bulk 18" x 26" White Towel with Patch - Bulk 18" x 26" White Fenestrated Towel 16" x 16" white Drape - Bulk 21" x 36" Clear Drape - Non-sterile 15.5" x 25" Blue Drape with 3/4" Adhesive Strip 26" x 22" Blue SMS Drape with 4 x 4 square Fenestration and Adhesive 26" x 21" Blue SMS Drape with 2" x 3" Oval Fenestration - Bulk non-sterile 18" x 26" White / BPP / White Drape with 3" Fenestration 26" x 21" Blue SMS Drape - Bulk 15.5" x 25" Blue Drape w/adhesive near folded edge - non-Sterile 15.5" x 26" Blue Utility Drape - Bulk 15.5" x 25" Non-Absorbent Utility Drape - Non-Sterile 15.5" x 25" Blue SMS Non-Absorbent Fenestrated Drape - Bulk 26" x 21" Blue SMS Drape With 2" x 3" Oval Fenestration and Adhesive Patch - Bulk Pain Management Drape with Fenestration & Adhesive Strip - 24" x 30" Clear drape - 690 24" X 30" Clear Drape with 4" x 8" Rectangular Fenestration and Adhesive strip 24" x 30" Clear Drape with 4" Fenestration, Adhesive Patch & Adhesive Tabs 30" x 24" Clear Drape with 4" Round Fenestration and Adhesive Strip Sterile Titan(TM) Quincke Style Spinal Needle 22G x 3 1/2" - 562 Sterile Titan(TM) Quincke Style Spinal Needle 20G x 3 1/2" - 561 Sterile Titan(TM) Quincke Style Spinal Needle 18G x 3 1 1/2" - 560 Sterile Titan(TM) Quincke Style Spinal Needle 22G x 1 1/2" - 564 Sterile Titan(TM) Quincke Style Long Length Spinal Needle 22G x 7" - 566 Sterile Titan(TM) Quincke Style Long Length Spinal Needle 22G x 5" - 565 Sterile Titan(TM) Quincke Style Spinal Needle 25G x 3 1/2" - 563 Procedural Mask Fluid Resistant Mask with Face Shields Fluid Resistant Mask Busse Thoracentesis Tray Nurses' Scissors Littauer Scissors with Plastic Handle SCISSORS DISPOSABLE I.V. Start Kit w/Tegaderm Dressing IV Start Kit w/ Sepp & Tegaderm Dressing Newborn Tape Measure Pediatric Tape Measure Measuring Devices Various Calculi Strainer Busse Eye Procedure Tray Basic Soft Tissue Biopsy Tray without Biopsy Needle Amber Vials #1, #2, #3 Clear Vials #1, #2, #3, #4, #5 Super-Step Shoe Covers Shoe Covers STERILE EPLIGLIDE TUOHY EPIDURAL NEEDLE 17G X 3.5" WITH FIXED WINGS - CAT. # 578 STERILE EPIGLIDE TUOHY EPIDURAL NEEDLE 18G X 3.5" WITH FIXED WINGS - CAT. # 581 STERILE EPIGLIDE TUOHY EPIDURAL NEEDLE 20G X 3.5" WITH FIXED WINGS - CAT. # 584 Obstetrical Kit Emergency OB Kit (Hard Pack) 40cc Specimen Trap 40cc Specimen Trap with Lid 80cc Specimen Trap Central Line Dressing Change Tray Central Line Dressing Change Tray with Chloraprep CVC Dressing Change Tray Central Line Dressing Tray CVC Insertion Kit Drainage Bag with Hook J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Acquisition Cannula Safety Deluxe Bone Marrow Biopsy Tray with Snare-It Biopsy needle/ aspiration needle Safety Deluxe Bone Marrow Biopsy Tray with Snare-It Biopsy Needle Sponge Bowls Specimen Container I-Style Bone Marrow Aspiration Needle Amniotic Perforator Tracheostomy Care Set Adson Serrated Forceps FORCEPS Posi-Grip (TM) Thumb Forceps SURGICAL CAP Surgeon's Cap Bouffant Cap

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Device in the United States for Export Only