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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 ReJoyce is a rehabilitation device intended to increase the strength of muscles and the range of motion of joints of the upper extremities. The ReJoyce helps patients to retrain and condition their muscles by using their hands and arms to play interactive computer games. The activities required by the computer games are similar to tasks used in everyday life, such as pouring a drink or opening a jar. Practicing these motions will help patients to replicate them in real life.
Rehabtronics Inc
RV10
In Commercial Distribution

  • 17540176010002 ()


  • Virtual-display arm rehabilitation system, non-gravity-compensating
This is a medical device.The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.The ELECTROmatic dental control unit is a stand-alone system for operating electrically-driven KaVo handpieces. External power supply provides electric power to the unit. The 4-hole tubing connected to the unit supplies chip /cooling air, water and pressure signal. The speed of the electric handpiece is controlled by air pressure. The control unit is positioned close to a treatment unit at thelocation preferred by the dentist. The ELECTROmatic system consists of a base unit with a motor hose, an electrical motor, a transformer, and a power cord. The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.
KaVo Dental GmbH
1.003.1107
In Commercial Distribution

  • EKAV100311070 ()
20 E

  • Dental power tool system handpiece, line-powered
X-Ray Detectable Sponges 4 x 8in.(10.2 x 20.3cm) 24-Ply Woven 100 percent cotton • With wavy Barium Sulfate Band • Non Sterile. Single Use Only. Not Made with Natural Rubber Latex. Store in a Cool, Dry Place. Avoid Direct Sunlight.
Cardinal Health 200, LLC
C-NXR4824
In Commercial Distribution

  • 50885380053366 ()
  • 20885380053365 ()
  • 00885380053361 ()
C-NXR4824

  • Radiopaque woven surgical sponge, non-sterile
The Liofilchem® MTS™ (MIC Test Strip) Eravacycline 0.002-32 µg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in µglmL of antimicrobial agents against bacteria as tested on agar media using ovemight incubation and manual reading procedures. The MTS™ Eravacycline at concentrations of 0.002-32 µglmL should be interpreted at 16-20 hours of incubation. MTS™ Eravacycline can be used to dete1mine the MIC of eravacycline against the following bacteria. Eravacycline has been shown to be active both clinically and in vitro against these bacterial species accoring to the FDA drug approved label: Gram-positive bacteria Enterococcus faecalis Enterococcus faecium Staphylococcus aureus Gram-negative bacteria Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Eravacycline has been shown to be active in vitro only against the non-fastidious bacteria listed below accoring to the FDA drug aprroved label: Citrobacter koseri Klebsiella (Enterobacter) aerogenes
LIOFILCHEM SRL
Eravacycline ERV 0.002-32 µg/mL 1 STRIP
In Commercial Distribution

  • 08055182872893 ()
  • 28055182872897 ()
  • 18055182872890 ()
92104-1

  • Eravacycline minimum inhibitory concentration (MIC) IVD
The Liofilchem® MTS™ (MIC Test Strip) Eravacycline 0.002-32 µg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in µglmL of antimicrobial agents against bacteria as tested on agar media using ovemight incubation and manual reading procedures. The MTS™ Eravacycline at concentrations of 0.002-32 µglmL should be interpreted at 16-20 hours of incubation. MTS™ Eravacycline can be used to dete1mine the MIC of eravacycline against the following bacteria. Eravacycline has been shown to be active both clinically and in vitro against these bacterial species accoring to the FDA drug approved label: Gram-positive bacteria Enterococcus faecalis Enterococcus faecium Staphylococcus aureus Gram-negative bacteria Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Eravacycline has been shown to be active in vitro only against the non-fastidious bacteria listed below accoring to the FDA drug aprroved label: Citrobacter koseri Klebsiella (Enterobacter) aerogenes
LIOFILCHEM SRL
Eravacycline ERV 0.002-32 µg/mL 10 STRIP
In Commercial Distribution

  • 18055182872906 ()
  • 08055182872909 ()
  • 08055182872886 ()
92104-10

  • Eravacycline minimum inhibitory concentration (MIC) IVD
X-Ray Detectable Sponges / 4 x 8in. (10.2 x 20.3cm) CAUTION: For External Use Only. 32-Ply Woven 100 percent Cotton with Wavy Barium Sulfate Band. Non Sterile. Single Use Only. Not Made with Natural Rubber Latex. Store in a Cool, Dry Place.
Cardinal Health 200, LLC
C-NXR4832
In Commercial Distribution

  • 50885380053373 ()
  • 20885380053372 ()
  • 00885380053378 ()
C-NXR4832

  • Radiopaque woven surgical sponge, non-sterile
Premium Gauze Sponges 2 x 2in. (5.1 x 5.1cm) 8 Ply. Woven 100 percent Cotton. CAUTION: For External Use Only. Non sterile. Single Use Only. Not Made with Natural Rubber Latex. Store in a Cool, Dry Place. Avoid Direct Sunlight.
Cardinal Health 200, LLC
C-NSG228
In Commercial Distribution

  • 50885380052932 ()
  • 20885380052931 ()
  • 00885380052937 ()
C-NSG228

  • Non-woven gauze pad, non-sterile
X-Ray Detectable Sponges 4 x 8in. (10.2 x 20.3cm) 12-Ply Woven 100 percent Cotton With Wavy Barium Sulfate Band CAUTION: For External Use Only. Non Sterile. Single Use Only. Not Made with Natural Rubber Latex. Store in a Cool, Dry Place.
Cardinal Health 200, LLC
C-NXR4812
In Commercial Distribution

  • 50885380130937 ()
  • 20885380130936 ()
  • 00885380130932 ()
C-NXR4812

  • Radiopaque woven surgical sponge, non-sterile
X-Ray Detectable Sponges 4 x 4in. (10.2 x 10.2cm) 16-Ply Woven 100 percent Cotton With Wavy Barium Sulfate Band CAUTION: For External Use Only. Non Sterile. Single Use Only. Not Made with Natural Rubber Latex. Store in a Cool, Dry Place.
Cardinal Health 200, LLC
C-NXR4416
In Commercial Distribution

  • 50885380130920 ()
  • 20885380130929 ()
  • 00885380130925 ()
C-NXR4416

  • Radiopaque woven surgical sponge, non-sterile
X-Ray Detectable Sponges 4 x 4in. (10.2 x 10.2cm) 24-Ply Woven 100 percent Cotton with Wavy Barium Sulfate Band. CAUTION: For External Use Only. Non Sterile. Single Use Only. Not Made with Natural Rubber Latex. Store in a Cool, Dry Place.
Cardinal Health 200, LLC
C-NXR4424
In Commercial Distribution

  • 50885380053328 ()
  • 20885380053327 ()
  • 00885380053323 ()
C-NXR4424

  • Radiopaque woven surgical sponge, non-sterile
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