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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 TORQUEMASTER 5 2-HOLE IS AN ADJUSTABLE SPEED UP TO 5000 RPM LOW SPEED PNEUMATIC DENTAL MOTOR, USED IN CONJUNCTION WITH OTHER ATTACHMENTS SUCH AS BURS AND MANDRELS WHICH CONNECTS TO AN OPERATORY TO DRILL BONE, TEETH AND TOUGH TISSUES IN A DENTAL SETTING. REMOVING CALCULUS AND POLISHING TEEETH
MTI Precision Products, LLC
LXTM52
In Commercial Distribution

  • D826LXTM520 ()
  • D826LXTM52 ()


  • Dental surgical power tool motor, pneumatic
SERIM GUARDIAN HiSENSE ULTRA 0.1 Test Strips indicates low levels of total chlorine (chloramines/free chlorine) in feed water used to prepare dialysate. The test also indicates the concentration of residual chlorine (chlorine bleach) remaining in the water used to rinse dialysate lines following disinfection of hemodialysis equipment.
SERIM RESEARCH CORPORATION
5167
In Commercial Distribution

  • M1745167IN2 ()
  • M17451671 ()
  • M17451672 ()
  • M17451670 ()
5167

  • Multi-parameter device tester
The Home Access A1c Test kit is an in vitro test for the quantitative measurement of Hemoglobin A1c using capillary blood. Measurements obtained through this test kit can be used for monitoring the long-term control of blood sugar (glucose) in people with diabetes. Contains space for Patient PCP information.
Home Access Health Corporation
84
In Commercial Distribution

  • M769A1CPCP841 ()


  • Capillary blood collection set, home-use
Dressing forceps are a type of surgical instrument commonly used in medical procedures, particularly in dressing wounds. The forceps are designed to hold dressings, swabs, or other materials during medical procedures. The dressing forceps are typically made of high-quality stainless steel and are approximately 13cm in length. They feature a long, thin handle with a curved or straight working end that is designed to grip and hold dressings or other materials. The working end of the dressing forceps may have a serrated pattern to provide a firm grip on the dressing or material being held. The forceps may also feature a locking mechanism to keep the dressing securely in place during the procedure. Overall, dressing forceps are a valuable tool in any medical setting and are commonly used in various procedures such as wound care, surgical dressing changes, and other procedures that involve the use of dressings or swabs. Their design allows for precise control and maneuverability when working with dressings or other materials.
CONCISE ENTERPRISES
150278813
In Commercial Distribution

  • G2021502788130 ()
15-02788-13

  • Surgical soft-tissue manipulation forceps, tweezers-like, single-use
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 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
1.012.8545
In Commercial Distribution

  • EKAV101285450 ()
TM-S

  • Dental delivery system
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 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
1.012.8539
In Commercial Distribution

  • EKAV101285390 ()
C-S

  • Dental delivery system
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 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
1.006.0800
In Commercial Distribution

  • EKAV100608000 ()
E675 LMW

  • Dental power tool system handpiece, pneumatic
Visicoil Multi-Market Patient Convenience Kit: Quantity of 8: SN-050-005-PL08. Which contains: 0.50mm x 0.5cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
KIT-SPN-8PL
In Commercial Distribution

  • EIBAKITSPN8PL0 ()
KIT-SPN-8PL

  • Radiological image marker, implantable
BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybride Composite and available in several shades. BRILLIANT EverGlow Flow Sample Pack Color A2/B2
Coltène/Whaledent AG
60019738
In Commercial Distribution

  • J00660019738 ()
60019738

  • Dental composite resin
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / COC / M-AMP / MTD / OPI / OPI-2000 / OXY / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7210-11
In Commercial Distribution

  • M90107RD7210110 ()

  • Length: 74 Millimeter
07RD7210-11

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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