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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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Magnetic particles with covalently bound oligonucleotide probes (400 mL x 20 ea)
EXACT SCIENCES CORPORATION
100699
In Commercial Distribution

  • 00850057859003 ()


  • Nucleic acid extraction/isolation kit IVD
Alair BT Controller - ROHS Refurbished
BOSTON SCIENTIFIC CORPORATION
ATS 200
In Commercial Distribution

  • 08714729961154 ()
M005ATS200RR0

  • Radio-frequency ablation system
Alair BT Controller - Refurbished
BOSTON SCIENTIFIC CORPORATION
ATS 200
In Commercial Distribution

  • 08714729802822 ()
M005ATS200R0

  • Radio-frequency ablation system
Bronchial Thermoplasty Catheter
BOSTON SCIENTIFIC CORPORATION
M005ATS25010
In Commercial Distribution

  • 08714729802792 ()

  • 150 cm Length
  • 2.0 mm Diameter
M005ATS25010

  • Radio-frequency ablation system
RF Controller Accessory Kit
BOSTON SCIENTIFIC CORPORATION
M005ATS20110
In Commercial Distribution

  • 08714729802778 ()
M005ATS20110

  • Radio-frequency ablation system
Alair BT Controller
BOSTON SCIENTIFIC CORPORATION
ATS 200
In Commercial Distribution

  • 08714729796695 ()
M005ATS20000

  • Radio-frequency ablation system
Models 400 and 550 Implantable Infusion Pump Refill Kit Contents: (1) 50 ml Calibrated Syringe Barrel (1) Tubing Set with Removable Injection Site (1) Stopcock (2) Huber Point Needles 22 Gauge x 1inch (2.54 cm) (2) Huber Point Needles 22 Gauge x 1.5inch (3.8 cm) (6) Gauze Pads (1) Fenestrated Drape (2) Pump Templates (2) Adhesive Bandages (1) Refill Worksheet (1) Set of INSTRUCTIONS FOR USE
Medos International Sàrl
IP40820US
Not in Commercial Distribution

  • 10886704078845 ()
IP40820US

  • Implantable intrathecal infusion pump, nonprogrammable
Genius AI® is a computer-aided detection and diagnosis (CADe/CADx) software device intended to be used with compatible digital breast tomosynthsis (DBT) systems to identify and mark regions of interest including soft tissue densities (masses, architectural distortions, and assymetries) and calcifications in DBT exams from compatible DBT systems and provide confidence scores that offer assessment for Certainty of Findings and a Case Score.
Hologic, Inc.
GENIUS AI DETECTION SOFTWARE
In Commercial Distribution

  • 15420045512474 ()
ASY-15431

  • Stationary mammographic x-ray system, digital
HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen).
FIDIA FARMACEUTICI SPA
FID185704
Not in Commercial Distribution

  • M71389122496630SAM1 ()
  • M71389122496630SAM0 ()

  • Total Volume: 3 Milliliter
FID185704

  • Synovial fluid supplementation medium
HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen).
FIDIA FARMACEUTICI SPA
89122-4966-30
Not in Commercial Distribution

  • M71389122496630A16 ()
  • M71389122496630A ()

  • Total Volume: 3 Milliliter
89122-4966-30

  • Synovial fluid supplementation medium
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