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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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Harmonic Synergy - 10705036002802

Harmonic Synergy Curved Blade with Torque Wrench. For use with Blue Hand Piece Only
ETHICON ENDO-SURGERY, LLC
SNGCB
In Commercial Distribution

  • 30705036002806 ()
  • 10705036002802 ()
  • 20705036002809 ()
SNGCB

  • Soft-tissue ultrasonic surgical system handpiece tip, single-use

DOA 1 PANEL TEST - 00817830020746

Immunoassay for the detection of the following drug substance(s) in human urine: PCP
RAPID DIAGNOSTICS INC
07RD7060-09
In Commercial Distribution

  • 00817830020746 ()

  • Length: 75 Millimeter
07RD7060-09

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

First Sign® - 00817763022145

DOA Single Test Dip card, 25Pcs/Box; First Sign for Hemosure, CLIA Waived PCP
HEMOSURE INC.
FSCDIPPC-25
In Commercial Distribution

  • 00817763022145 ()
  • 00817763022152 ()


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

Porges Coloplast - 03600040325087

In-Ka® Percutaneous Balloon Dilatation Catheter Balloon dilation catheter for percutaneous access + inflation device
Coloplast A/S
BD3020
In Commercial Distribution

  • 03600040325087 ()

  • Outer Diameter: 10 Millimeter
  • Length: 55 Centimeter
BD3020

  • Endoscopic-access dilator, single-use

AMShield® Disinfecting Cap - 30704411011877

AMShield® Disinfecting Cap Contains 70% IPA for Needle-Free Valves 200 PCS Individually Packed
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411011874 ()
  • 30704411011877 ()
  • 00704411011876 ()
DCF2000

  • Luer-formatted disinfection cap

Curos™ Tego® - 30707387773817

3M™ Curos™ Disinfecting Cap for Tego® Hemodialysis Connectors US - CTG1- 270
3M COMPANY
CTG1-270
In Commercial Distribution

  • 50707387773811 ()
  • 30707387773817 ()
  • 00707387773816 ()
CTG1-270

  • Luer-formatted disinfection cap

Curos™ - 30707387773794

3M™ Curos™ Tips™ Disinfecting Cap Strip for Male Luers US - CM5-200
3M COMPANY
CM5-200
In Commercial Distribution

  • 50707387773798 ()
  • 30707387773794 ()
  • 00707387773793 ()
CM5-200

  • Luer-formatted disinfection cap

EDEGENDO - 06944843619095

EDGEAPEX is a microprocessor controlled device intended for locating the apex of root canal.
Guilin Woodpecker Medical Instrument Co., Ltd.
EDGEAPEX
In Commercial Distribution

  • 06944843619095 ()


  • Endodontic apex locator

6% NaOCL Sodium Hypochlorite - 10818207020441

For debridement and irrigation of root canals during or after instrumentation. 32 ounce bottle.
Vista Dental
281403
Not in Commercial Distribution

  • 10818207020441 ()
  • 00818207020444 ()


  • Antimicrobial wound irrigation solution

3% NaOCL Sodium Hypochlorite - 10818207020427

For the debridement and irrigation of root canals during and after instrumentation. 12ml kit.
Vista Dental
502315
In Commercial Distribution

  • 10818207020427 ()
  • 00818207020420 ()


  • Antimicrobial wound irrigation solution
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