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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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V100 GENERIC ATO MODEL
Ge Medical Systems Information Technologies, Inc.
V100
In Commercial Distribution

  • 00840682103091 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
GE Medical Systems (China) Co.,Ltd.
V2
In Commercial Distribution

  • 00840682102933 ()


  • General-purpose ultrasound imaging system
No Description
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
E9
In Commercial Distribution

  • 00840682102377 ()

  • Width: 585 Millimeter
  • Height: 1300 Millimeter
  • Depth: 830 Millimeter


  • General-purpose ultrasound imaging system
The Piezosurgery® Plus is an ultrasonic surgical system consisting of handpieces and associated tips for osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to: - Otolaryngology - Oral/maxillofacial - Hand and foot - Neurosurgery - Spine - Plastic/reconstructive, and - Orthopedic surgery The device may also be used with endoscopic visual assistance to perform the above listed procedures.
MECTRON SPA
PIEZOSURGERY PLUS - US
In Commercial Distribution

  • E322051700030020 ()
05170003-002

  • Dental ultrasonic surgical system
  • Hard/soft-tissue ultrasonic surgical system
The PIEZOSURGERY FLEX -US is an ultrasonic surgical system consisting of handpieces and associated tips for cutting bone, osteotomy, osteoplasty and drilling in variety of surgical procedures, including but not limited to otolaryngological, oral/maxillofacial, hand, foot, neurosurgical, spine, and plastic/reconstructive surgery. It may also be used with endloscopic visual assistance to perform the above listed procedures.
MECTRON SPA
PIEZOSURGERY FLEX -US
In Commercial Distribution

  • E322051700020020 ()
05170002-002

  • Dental ultrasonic surgical system
MT-Bone is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for: - Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic and surgical endodontic procedures; - Scaling applications, including: Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits; o Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning; o Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha condensation and retrograde preparation; o Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
MECTRON SPA
MT-Bone -US-
In Commercial Distribution

  • E322051200652020 ()
05120065-202

  • Ultrasonic dental scaling/debridement system
  • Dental ultrasonic surgical system
PIEZOSURGERY GP is a piezoelectric device, consisting of handpiece and associated tip inserts, intended for: 1) Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures.including implantalogy, periodontal surgery, surgical orthodontic, and surgical endodonticprocedures; 2) Scaling applications, including: - Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits - Perlodontology: Periodontal therapy and debridenient for all types of periodontal diseases,including periodontal pocket irrigation and cleaning: - Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-perchacondensation and retrograde preparation; - Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
MECTRON SPA
PIEZOSURGERY GP
In Commercial Distribution

  • E322051200630010 ()
05120063-001

  • Ultrasonic dental scaling/debridement system
  • Dental ultrasonic surgical system
PIEZOSURGERY ® TOUCH -prof. Intl. -US- is a piezoelectric device, consisting of handpiece and associated tip inserts, intended for: 1) Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures.including implantalogy, periodontal surgery, surgical orthodontic, and surgical endodonticprocedures; 2) Scaling applications, including: - Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits - Perlodontology: Periodontal therapy and debridenient for all types of periodontal diseases,including periodontal pocket irrigation and cleaning: - Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-perchacondensation and retrograde preparation; - Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
MECTRON SPA
PIEZOSURGERY ® TOUCH -prof. Intl. -US-
In Commercial Distribution

  • E322051200620300 ()
051200062-030

  • Ultrasonic dental scaling/debridement system
  • Dental ultrasonic surgical system
Piezosurgery Touch -essential -US- is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for: · 1) Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures; 2) Scaling applications, including: • Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits; • Perlodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket Irrigation and cleaning; • Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha condensation and retrograde preparation; • Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
MECTRON SPA
PIEZOSURGERY ® TOUCH -essential -US-
In Commercial Distribution

  • E322051200620280 ()
05120062-028

  • Ultrasonic dental scaling/debridement system
  • Dental ultrasonic surgical system
The COMPACT PIEZO LED -B- DBI is an ultrasonic scaler device intended for use, with the appropriate associated insert tips, in the following dental applications: • Scaling: Procedures for removal of supragingival/subgingival and interdental calculus/plaque deposits; • Periodontology: Periodontal therapy and debridement for periodontal diseases, including periodontal pocket irrigation and cleaning; • Endodontics: Treatments for root canal reaming irrigation, revision, filling, gutta-percha condensation and retrograde preparation; • Restorative and Prosthetics: Restorative procedures including cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations, inlay/onlay condensation and implants/restorations cleaning.
MECTRON SPA
COMPACT PIEZO LED -B- DBI
In Commercial Distribution

  • E322050900080120 ()
05090008-012

  • Ultrasonic dental scaling/debridement system
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