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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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CRIMPABLE STOP 2MM 19 I.D. X 30 O.D. PK40
ORMCO CORPORATION
623-0262
In Commercial Distribution

  • 20889989055010 ()
  • 00889989055016 ()

  • 019 ID X 030 OD


  • Orthodontic bracket, metal
Software: The True 3D Viewer Software is intended for processing, review, analysis, communication and media interchange of digital images acquired from CT, MRI and Ultrasound sources. It is also intended as software for pre-operative analysis of surgical options. The True 3D Viewer Software is designed for use only with performance tested hardware specified in the user documentation. The device is intended to be used by health care professionals, who are responsible for making all final patient management decisions.
ECHOPIXEL, INC.
EP-00003
In Commercial Distribution

  • 00851325007003 ()
SW-0001-1601

  • Radiology picture archiving and communication system workstation
  • Radiology DICOM image processing application software
Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations. Also Provide Protection Against Irritants from Restoratives or Auxiliary Materials. Dentin Shade Syringe. Ziploc Bag. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 75-035 IZ
In Commercial Distribution

  • D801ID75035IZ1 ()
75-035

  • Dental cavity varnish
Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 60 gram Green Gel Etch Refill Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 70-125 BI
In Commercial Distribution

  • D801ID70125BI1 ()
70-125

  • Dental etching solution
SciPharm CuRay Match Metal Primer for Veneers or Cast Restorations (Primet). Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 7010 I
In Commercial Distribution

  • D801ID7010I1 ()
70-10

  • Dental composite resin
SciPharm CuRay Match Metal Primer for Veneers or Cast Restorations (Primet). Boxed. Italian
SCIENTIFIC PHARMACEUTICALS, INC.
ID 70-10 BI
In Commercial Distribution

  • D801ID7010BI1 ()
70-10

  • Dental composite resin
CuRay Support P/L - Self and Light Cured Core Build-Up Restorative. Activator Paste Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 55-304 I
In Commercial Distribution

  • D801ID55304I1 ()
55-304

  • Dental composite resin
CuRay Support P/L - Self and Light Cured Core Build-Up Restorative. Activator Liquid Bottle. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 55-303 I
In Commercial Distribution

  • D801ID55303I1 ()
55-303

  • Dental composite resin
CuRay Support P/L - Self and Light Cured Core Build-Up Restorative. Part A, Natural Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 55-302 I
In Commercial Distribution

  • D801ID55302I1 ()
55-302

  • Dental composite resin
CuRay Support P/L - Self and Light Cured Core Build-Up Restorative. Contrast Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 55-301 I
In Commercial Distribution

  • D801ID55301I1 ()
55-301

  • Dental composite resin
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