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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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The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display.
AIR TECHNIQUES, INC.
D5000F
In Commercial Distribution

  • D678D5000F0 ()
  • D678D5000F1 ()

  • Weight: 43 Pound
  • Height: 14 Inch
  • Length: 18 Inch
  • Width: 15.5 Inch


  • Radiography digital imaging scanner
AH Plus Jet Refill Kit is a 2 component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Jet is received in a syringe (D010606201180) delivery for homogeneous mixing of both pastes.
Dentsply De Trey GmbH
60620118
In Commercial Distribution

  • D010606201181 ()
  • D010606201180 ()

  • Weight: 15 Gram
  • Paste
60620118

  • Endodontic filling/sealing material
"Accommodates Zirc's 12 & 22 Hole Bur Guards Enables long and short burs to be used in the same bur guard without the short burs falling out Autoclavable up to 136°C/275°F Washer-disinfect"
ZIRC DENTAL PRODUCTS, INC.
50Z412
In Commercial Distribution

  • 10840161301953 ()
  • 00840161301956 ()

  • Length: 12.7 Millimeter
  • Width: 11.1 Millimeter
  • Height: 12.7 Millimeter


  • Instrument transport trolley system
CovoraTM is a sterile,single use device intended for use in partial thickness burns. CovoraTM is a soft, conformable, non-friable, absorbable matrix that provides an environment for the body’s natural healing process to occur
Acera Surgical Inc
COV1-10X12.5
In Commercial Distribution

  • 00854258006228 ()

  • Width: 12.5 Centimeter
  • Length: 10.0 Centimeter


  • Bioabsorbable wound dressing
CovoraTM is a sterile,single use device intended for use in partial thickness burns. CovoraTM is a soft, conformable, non-friable, absorbable matrix that provides an environment for the body’s natural healing process to occur
Acera Surgical Inc
COV1-7.5X7.5
In Commercial Distribution

  • 00854258006211 ()

  • Width: 7.5 Centimeter
  • Length: 7.5 Centimeter


  • Bioabsorbable wound dressing
CovoraTM is a sterile,single use device intended for use in partial thickness burns. CovoraTM is a soft, conformable, non-friable, absorbable matrix that provides an environment for the body’s natural healing process to occur
Acera Surgical Inc
COV1-5X5
In Commercial Distribution

  • 00854258006204 ()

  • Width: 5.0 Centimeter
  • Length: 5.0 Centimeter


  • Bioabsorbable wound dressing
The Piccolo® Lipid Panel reagent disc, 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), and triglycerides (TRIG) 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 these 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. This test is waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the test is 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.
400-0025
In Commercial Distribution

  • EABA40000251 ()
  • EABA40000250 ()
400-0025

  • Glucose/ketone/lipid profile IVD, reagent
A device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose. This kit contains an installation disc, USB cable and power supply, PSPs, barrier envelopes, barrier film rolls, PSP wipes, and a scanner cleaning sheet.
AIR TECHNIQUES, INC.
G8010
In Commercial Distribution

  • D678G80001 ()
  • D678G80100 ()
  • D678G80101 ()

  • Weight: 14.5 Pound
  • Outer Diameter: 9.6 Inch
  • Height: 9.2 Inch
  • Width: 8.9 Inch


  • Radiography digital imaging scanner
Malibu Deformity Hook Implant. The Malibu system contains polyaxial screws of varying reduction height, cannulated polyaxial screws of varying reduction height, uniplanar screws of varying reduction height, monoaxial screws, iliac onoaxial screws, rods, rod connectors, screw spacers, crossbars, sublaminar wires and hooks. Implants are offered in a variety of lengths to accommodate variations in patient anatomy and are manufactured from Titanium 6Aluminum-4Vanadium ELI, with the exception of the Malibu and NewPort Cobalt.
Seaspine Orthopedics Corporation
MLBDHIMP
In Commercial Distribution

  • 10889981028121 ()
MLBDHIMP

  • Vertebral body prosthesis, non-sterile
4.0mm Self Tapping Occipital Screw, 16mm. 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
16-32-4016
In Commercial Distribution

  • 10889981034337 ()

  • 4.0mm, 16mm
16-32-4016

  • Bone-screw internal spinal fixation system, non-sterile
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