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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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4.0mm x 28mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-13-4028
In Commercial Distribution

  • 10889981052805 ()

  • 4.0mm x 28mm
16-13-4028

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm x 38mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-13-3538
In Commercial Distribution

  • 10889981052744 ()

  • 3.5mm x 38mm
16-13-3538

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm x 36mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-13-3536
In Commercial Distribution

  • 10889981052737 ()

  • 3.5mm x 36mm
16-13-3536

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm x 20mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-13-3520
In Commercial Distribution

  • 10889981052652 ()

  • 3.5mm x 20mm
16-13-3520

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm x 18mm Smooth Shaft Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-13-3518
In Commercial Distribution

  • 10889981052645 ()

  • 3.5mm x 18mm
16-13-3518

  • Bone-screw internal spinal fixation system, non-sterile
The product is suitable for patients with certain hand movement ability, which can improve the precise control ability of the hand through assisting the hand to realize different gestures and movements. In addition, it can be applied in various training modes such as passive training, mirror training, active training, resistance training, power-assisted training and voice control training, to stimulate and intervene patients' central and peripheral nerves, which is helpful to the recovery of hand movement function of patients.
Shanghai SiYi Intelligent Technology Co., Ltd.
SY-HR
In Commercial Distribution

  • 06973408900019 ()
BXB

  • Hand/wrist continuous passive motion exerciser
PRIME&BOND XP REFILL is a universal Total-Etch Dental Adhesive. Prime&Bond XP Refill is received in a bottle delivery (D010K3027610). With its supporting accessories (Applicator Tips and Clixdish) it can be classified as a convenience kit.
Dentsply De Trey GmbH
60667281
In Commercial Distribution

  • D010606672811 ()

  • Total Volume: 5 Milliliter
  • Liquid
60667281

  • Dentine adhesive
The MVD-70, Pocket Neb is an electronic vibrating mesh nebulizer designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric and adult patients in and out of the home environment.
MICROVAPOR DEVICES, LLC
MVD-70
In Commercial Distribution

  • 10856702006010 ()
  • 00856702006013 ()


  • Ultrasonic nebulizing system
The Status® CS Acute Care(TM) Beta human Chorionic Gonadotropin CalPak calibrator (ßhCG CalPak) is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care(TM) ßhCG method.
Siemens Healthcare Diagnostics Inc.
10445061
In Commercial Distribution

  • 00842768004414 ()
  • 00630414009766 ()
CBHCG-C

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay
The Piccolo® Lipid Panel Plus, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended for the in vitro quantitative determination of total cholesterol (CHOL), high-density lipoprotein cholesterol (HDL), triglycerides (TRIG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and glucose (GLU) in capillary (fingerstick) lithium heparinized whole blood, venous lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. From the CHOL, HDL and TRIG determinations, low-density lipoprotein cholesterol (LDL), very low-density lipoprotein cholesterol (VLDL), non-HDL cholesterol, and a total cholesterol/high-density lipoprotein cholesterol ratio (TC/H) are calculated by the analyzer. Lipid measurements are used in the diagnosis and treatment of lipid and lipoprotein disorders, atherosclerosis, various liver and renal diseases, diabetes mellitus, and other diseases involving lipid metabolism or various endocrine disorders. The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood (venous or capillary) may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0030
In Commercial Distribution

  • EABA40000301 ()
  • EABA40000300 ()
400-0030

  • Glucose/ketone/lipid profile IVD, reagent
  • Alanine aminotransferase (ALT) IVD, reagent
  • Glucose IVD, reagent
  • Total aspartate aminotransferase (AST) IVD, reagent
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