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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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MiniFX
INMODE M.D LTD
AG604696A
In Commercial Distribution

  • 07290016633238 ()
AG604696A

  • Radio-frequency skin surface treatment system
BodyFX
INMODE M.D LTD
AS600874A
In Commercial Distribution

  • 07290016633085 ()
AS600874A

  • Radio-frequency skin surface treatment system
Thermal Regulating System
Gentherm Medical, LLC
542
In Commercial Distribution

  • 20613031825425 ()
  • 10613031825428 ()

  • Width: 50.0 Inch
  • Length: 72.0 Inch
  • Weight: 0.7 Pound
82542

  • Circulating-air whole-body heating/cooling system pad, single-use, sterile
Fractora 24P
INMODE M.D LTD
AG602426A
In Commercial Distribution

  • 17290016633150 ()
  • 07290016633153 ()
AG602426A

  • Radio-frequency skin surface treatment system
Porcelain Repair Kit (Clear) includes 1 (2.5 cc) PorcelETCH™ Clear, 3 of 25-gauge Blue Luer Lock Tips, 1 (10 mL) Bottle of Silanator™, 1 (3 g) GINGA-Guard syringe, 3 of White nozzle, 3 of 16 gauge Black Luer Lock Tips, 1 (2.5 g) Creative Color Opaquer Pink syringe, 1 Cosmedent #1 brush, and 1 (6 mL) Complete Primer/Unfilled Resin (Red Cap) in the Tray.
COSMEDENT, INC.
661015
In Commercial Distribution

  • D7796610153 ()
661015

  • Dental repair kit, ceramic
Porcelain Repair Kit (Green) includes 1 (2.5 cc) PorcelETCH™ Green, 3 of 25-gauge Blue Luer Lock Tips, 1 (10 mL) Bottle of Silanator™, 1 (3 g) GINGA-Guard syringe, 3 of White nozzle, 3 of 16 gauge Black Luer Lock Tips, 1 (2.5 g) Creative Color Opaquer Pink syringe, 1 Cosmedent #1 brush, and 1 (6 mL) Complete Primer/Unfilled Resin (Red Cap) in the Tray.
COSMEDENT, INC.
661005
In Commercial Distribution

  • D7796610053 ()
661005

  • Dental repair kit, ceramic
Alpha-Seal® is a light cure resin-based Pit & Fissure Sealant with fluoride. This sealant contains 50% radiopaque nano-sized fillers. The hard setting, wear resistant material has an ideal flowable viscosity for maximum coverage and protection to seal the pits and fissures of teeth suseptible to caries. The syringe needle tips allow for quick and accurate placement of the material. Alpha-Seal® is available in Opaque shade to allow for easy identification during patient examinations and in a Clear shade for patients who wish to have an "invisible" sealant. Kit Contains: 3 x 1g Sealant Syringe (Clear), 10 Dispensing Tips, 1 x 4g Alpha-Etch® 37 Syringe, 10 Dispensing Tips, 20 Disposable Brushes
DENTAL TECHNOLOGIES, INC.
401.0010.002
In Commercial Distribution

  • D73540100100020 ()
401.0010.002

  • Dental pit/fissure sealant
Alpha-Seal® is a light cure resin-based Pit & Fissure Sealant with fluoride. This sealant contains 50% radiopaque nano-sized fillers. The hard setting, wear resistant material has an ideal flowable viscosity for maximum coverage and protection to seal the pits and fissures of teeth suseptible to caries. The syringe needle tips allow for quick and accurate placement of the material. Alpha-Seal® is available in Opaque shade to allow for easy identification during patient examinations and in a Clear shade for patients who wish to have an "invisible" sealant. Kit Contains: 3 x 1g Sealant Syringe (Opaque White), 10 Dispensing Tips, 1 x 4g Alpha-Etch® 37 Syringe, 10 Dispensing Tips, 20 Disposable Brushes
DENTAL TECHNOLOGIES, INC.
401.0009.002
In Commercial Distribution

  • D73540100090020 ()
401.0009.002

  • Dental pit/fissure sealant
The EXOGEN Ultrasound Bone Healing System provides non-invasive therapy for healing non-unions and accelerating time to healing of fresh fractures. EXOGEN is designed both for use with conservatively treated fresh fractures and non-unions, or surgically-treated non-unions. EXOGEN transmits a low-intensity ultrasound signal to the fracture site through coupling gel, with little or no sensation felt by the patient during the treatment. Low-intensity pulsed ultrasound has been shown in in-vitro and in-vivo studies to stimulate cells to produce growth factors and proteins that are important to bone healing. The patient administers treatment at home or at work, once daily, for 20 minutes, or as prescribed by a physician. EXOGEN automatically alerts the patient in case of improper application or performance. The EXOGEN Ultrasound Bone Healing System consists of one EXOGEN device, a charger, a gel bottle and strap. The EXOGEN device provides the treatment control circuitry, the battery supply and monitors the operation of the transducer at the fracture site. Thesignal specifications cannot be changed.
BIOVENTUS LLC
71034400
In Commercial Distribution

  • M937710344001 ()
71034400

  • Bone growth ultrasonic stimulator
  • Radiographic image marker, manual
  • Skin topical coupling gel
  • Personal device holder, single-use
  • Noninvasive device battery charger
The EXOGEN device provides non-invasive therapy for healing non-unions and accelerating time to healing of fresh fractures. The EXOGEN Ultrasound Bone Healing Systems has been designed both for use with conservatively treated fresh fractures and non-unions or surgically treated non-unions. The device transmits a low intensity ultrasound signal to the fracture site through coupling gel, with little or no sensation felt by the patient during the treatment. The low-intensity pulsed ultrasound has been shown in in-vitro and in-vivo studies to stimulate cells to produce growth factors and proteins that are important to bone healing. The patient administers treatment at home or at work, once daily, for 20 minutes, or as prescribed by a physician. The device automatically alerts the patient in case of improper application or device performance. The EXOGEN Ultrasound Bone Healing System consists of one main operating unit, gel bottles and strap. The main operating unit provides the treatment control circuitry, the primary battery supply, and monitors the operation of the transducer at the fracture site. The signal specifications cannot be changed.
BIOVENTUS LLC
71034600
In Commercial Distribution

  • M937710346001 ()
71034600

  • Bone growth ultrasonic stimulator
  • Radiographic image marker, manual
  • Skin topical coupling gel
  • Personal device holder, single-use
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