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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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SPEAX Patch - B792FGN002

Patch for use with the SPEAX Communication System
ATAIA INC.
FGN-002
In Commercial Distribution

  • B792FGN003 ()
  • B792FGN002 ()
  • B792FGN012 ()
FGN002

  • Voice amplification system

OLO CBC Test Kit - B787TK10

A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
S.D. SIGHT DIAGNOSTICS LTD
TK1
In Commercial Distribution

  • B787TK10 ()
  • B787TK11 ()
  • B787TK12 ()


  • Full blood count IVD, kit, cell count

COE® - D6582672011

COE® Check-Bite™ #72, Unilateral, Non-Water Cooled
Gc America Inc.
267201
In Commercial Distribution

  • D6582672012 ()
  • D6582672011 ()
  • D6582672014 ()
  • D6582672010 ()
267201

  • Dental impression tray, reusable

COE® - D6582670011

COE® Check-Bite™ #70, Unilateral, Water Cooled, for Hydrocolloid
Gc America Inc.
267001
In Commercial Distribution

  • D6582670012 ()
  • D6582670011 ()
  • D6582670014 ()
  • D6582670010 ()
267001

  • Dental impression tray, reusable

COE® - D6582643311

COE® Stainless Steel-Perforated Partials Individual Tray #S33 Anterior Upper
Gc America Inc.
264331
In Commercial Distribution

  • D6582643314 ()
  • D6582643312 ()
  • D6582643311 ()
264331

  • Dental impression tray, reusable

COE® - D6582643211

COE® Stainless Steel-Perforated Partials Individual Trays #S32 Anterior Lower
Gc America Inc.
264321
In Commercial Distribution

  • D6582643212 ()
  • D6582643211 ()
  • D6582643214 ()
264321

  • Dental impression tray, reusable

COE® - D6582643011

COE® Stainless Steel-Perforated Partials Individual Trays #S30 Right Unilateral
Gc America Inc.
264301
In Commercial Distribution

  • D6582643014 ()
  • D6582643012 ()
  • D6582643011 ()
264301

  • Dental impression tray, reusable

COE® - D6582642211

COE® Stainless Steel-Perforated Individual Tray #S22 Lower
Gc America Inc.
264221
In Commercial Distribution

  • D6582642214 ()
  • D6582642212 ()
  • D6582642211 ()
264221

  • Dental impression tray, reusable

COE® - D6582642111

COE® Stainless Steel-Perforated Individual Tray #S21 Lower
Gc America Inc.
264211
In Commercial Distribution

  • D6582642112 ()
  • D6582642111 ()
  • D6582642114 ()
264211

  • Dental impression tray, reusable

COE® - D6582642011

COE® Stainless Steel-Perforated Individual Tray #S20 Lower
Gc America Inc.
264201
In Commercial Distribution

  • D6582642014 ()
  • D6582642012 ()
  • D6582642011 ()
264201

  • Dental impression tray, reusable
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