Profile: Spectra Medical Devices, Inc. is an OEM manufacturer of Custom Tray Components and Instruments. We specialize in Custom OEM Needles, Surgical and Dental Disposable Instruments. We are an ISO 9001 certified company. We provide Complete Engineering and R&D Services.
We also offer glass syringes, strap clips and surgical disposables, such as scalpels & blades. Our surgical product line includes scissors, sutures, trocars and general instrument. Our Custom Needles are made with stainless steel material. We also provide Hypodermic Tubing & Wire with standard and tight tolerances.
The company was founded in 1995, has revenues of USD 5-10 Million, has ~20 employees.
FDA Registration Number: 1224960
• Adult Bedpans |
• Aluminum Hub Spinal Introducer Needles |
• Anesthesia Conduction Kit (FDA Code: CAZ / 868.5140) An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs. |
• Anesthesia Syringe |
• Anesthesia Syringe Labels |
• Anesthetic Conduction Needle with/without Introducer (FDA Code: BSP / 868.5150) An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia. |
• Applicator |
• Aspiration Syringe |
• Bedpans & Urinals |
• Blood Gas Capillary Tubes |
• Blood Gas Capillary Tubes Balanced Heparin |
• Blood Gas Capillary Tubes Sodium Heparin |
• Bone Marrow Biopsy Needle |
• Bone Surgery Surgical Instrument |
• Brachytherapy, Implant Needles |
• Bulk Disposable Scalpels |
• Capillary Tube Accessories |
• Capillary Tube Sealers |
• Cardiovascular Surgical Instrument (FDA Code: DWS / 870.4500) Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors. |
• Catheter Introducers (FDA Code: DYB / 870.1340) A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery. |
• Child Bedpans |
• Common Surgical Instrument |
• Contract Manufacturing |
• Disposable Glass Syringes |
• Disposable Prostate Seed Needles |
• Disposable Scalpels |
• Disposable Surgical Blades |
• Disposable Surgical Drape (FDA Code: KKX / 878.4370) A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy. |
• Dissecting Scalpel Blades |
• ENT Surgical Drapes (FDA Code: ERY / 878.4370) |
• Epidural Anesthesia Needle |
• Epidural Catheter Kit |
• Epidural Catheters |
• Fluid Delivery Tubing (FDA Code: FPK / 880.5440) An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container. |
• Garbage Bag |
• General Purpose Surgical Drapes |
• General Surgical Manual Instrument (FDA Code: MDM / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892. |
• Glass Syringes, Reusable |
• Guide Wire Introducer Needles |
• Hematology Quantitative Pipette (FDA Code: GJG / 864.6160) A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets. |
• Heparinized Capillary Tubes |
• Hospital Bedpans |
• Hospital Silicone Tubing |
• Huber Needles |
• Hypodermic Cannula Tubing |
• Hypodermic Needle Tubing |
• Hypodermic Tubing & Wire |
• Infection Control Laundry Bag |
• Interventional Cardiology Surgical Drapes |
• Intra-Arterial Administration Kit |