BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TRINITY STERILE, INC.

    Reg #: 1123010 · FEI: 1000123297 · Expires 2026
    View on FDA
    Products
    79
    Proprietary Names
    74
    Establishment Types
    4
    Classifications
    79

    Registration Details

    Registration Name
    TRINITY STERILE, INC.
    Registration Number
    1123010
    FEI Number
    1000123297
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    201 Kiley Dr
    City
    SALISBURY
    State
    MD
    ZIP
    21801
    Country
    US

    Regulatory Submissions

    510(k) Number
    K920517

    Owner / Operator

    Firm Name
    TRINITY STERILE, INC.
    Operator Number
    9003800
    Address
    201 KILEY DR., --
    City
    Salisbury
    State
    MD
    Postal Code
    21801
    Country
    US

    Products

    Device Name Product Code
    Mouthpiece, Saliva Ejector DYN
    Suture Removal Kit MCZ
    Forceps, General & Plastic Surgery GEN
    Forceps, Ent KAE
    Fiber, Medical, Absorbent FRL
    Catheters, Suction, Tracheobronchial BSY
    Spatula, Ophthalmic HND
    Drape, Surgical, Antimicrobial KKX
    Pessary, Vaginal HHW
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Bedding, Disposable, Medical KME
    Elevator, Surgical, Dental EMJ
    Clamp, Circumcision HFX
    Ligator, Hemorrhoidal FHN
    Endoscopic Bite Block MNK
    Kit, Surgical Instrument, Disposable KDD
    Orthopedic Manual Surgical Instrument LXH
    Phlebotomy Blood Collection Kit OFM
    Tray, Biopsy, Without Biopsy Instruments FCH
    Dressing Change Tray OXQ
    Sound, Uterine HHM
    Urinary Drainage Collection Kit, For Indwelling Catheter FCN
    Sound, Urethral, Metal Or Plastic FBX
    File, Bone, Surgical EMI
    Forceps, Obstetrical HDA
    Handle, Scalpel GDZ
    Catheter And Tip, Suction JOL
    Blade, Scalpel GES
    Cannula, Ear JYC
    Aspiration Tray OJT
    Saw, Manual And Accessories GDR
    Hook, Microsurgical Ear JYL
    Speculum, Vaginal, Metal HDF
    Explorer, Operative EKB
    Mirror, Mouth EAX
    Instrument, Manual, Surgical, General Use MDM
    Instrument, Ent Manual Surgical LRC
    Accessories, Catheter KGZ
    Syringe, Irrigating (Non Dental) KYZ
    Plier, Orthodontic JEX
    Tray, Surgical, Instrument FSM
    Forceps HTD
    Scissors, General, Surgical LRW
    Continuous Measurement Thermometer FLL
    Tracheotomy Care Kit NXA
    Speculum, Vaginal, Nonmetal HIB
    Retractor GAD
    Curette, Surgical, General Use FZS
    Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua QKR
    Tray, Surgical LRP
    Bandage, Elastic FQM
    Speculum, Rectal FFQ
    Staple, Removable (Skin) GDT
    Ring Cutter FNS
    Curette, Ear JYG
    Accessories, Cleaning Brushes, For Endoscope MNL
    Tape And Bandage, Adhesive KGX
    Guide, Surgical, Instrument FZX
    Probe, Lachrymal HNL
    Holder, Needle; Orthopedic HXK
    Tenaculum, Uterine, Exempt PUA
    Formalin-Saline IGC
    Punch, Biopsy, Surgical EME
    Laparoscope, General & Plastic Surgery GCJ
    General Surgery Tray LRO
    Clamp, Surgical, General & Plastic Surgery GDJ
    Scalpel, One-Piece GDX
    Cutter, Surgical FZT
    Screw, Oral KBW
    Tourniquet, Nonpneumatic GAX
    Punch, Surgical LRY
    Fork, Tuning GWX
    Spatula, Surgical, General & Plastic Surgery GAF
    Rongeur HTX
    Instruments, Surgical, Cardiovascular DWS
    I.V. Start Kit LRS
    Laceration Tray PKD
    Splint, Hand, And Components ILH
    Clamp, Penile FHA

    Proprietary Names

    Aspirator Suture Removal Kit Forceps Ear Forceps Kit Spatula Minor Laceration Tray Pessary Fox Eye Shield Disposable Underpad Elevator Mogen Clamp Hemorrhoidal Ligator Bite Block Tray Staple Remover Wire Knot Tightener Phlebotomy Kit Dressing Change Tray Uterine Sound Urethral Sound Bone File Port Access Tray Dressing Tray Obstetrical Forceps Scalpel Handle Scalpel Blade Joint Aspiration Tray Gigli Saw Micro Ear Hook Vaginal Speculum - Metal Explorer Wound Care Kit Laryngeal Mirror Comedone Extractor Foreign Body Instrument Bandage Plier Scissors Infrared Thermometer Trach Care Kit Vaginal Speculum - Non-Metal Retractor Curette Face Mask Rectal Speculum Ring Cutter Disposable Ear Curette Brushes Tape Kit Traction Bow Lachrymal Probe Needle Holder Tenaculum Laparoscopic Instruments Dental Care Kit Clamp Scalpel Cutter Oral Screw Plastic Tourniquet Biopsy Punch Tuning Fork Esophageal Spoon and Spatula Rongeur Bulldog Clamp I.V. Start Kit AMS-905CS-1 AMS-823CP AMS-623TG-6LF AMS-872CP-1 AMS-744CP Laceration Tray Hand Fixation Device Stockman/Zipser Penis Clamp

    Establishment Types

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