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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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OtoNova Pro Screener DP - 05060396173110

OtoNova Pro system for DPOAE hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DP Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-D
In Commercial Distribution

  • 05060396173110 ()


  • Otoacoustic emission system, battery-powered

OtoNova Pro Screener TE - 05060396173103

OtoNova Pro system for TEOAE hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and TE Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-T
In Commercial Distribution

  • 05060396173103 ()


  • Otoacoustic emission system, battery-powered

Natural Cycles - 07350014630131

Package for 6-month subscription of Natural Cycles. Includes a Basal Body Thermometer and a subscription code for 6 months access to the app.
Naturalcycles Nordic AB
13
In Commercial Distribution

  • 07350014630131 ()


  • Self-care monitoring/reporting software

HEPRO.US - Syringe with attached needle 5ml/cc 22G x1" - 00850578007273

Hepro.us - Syringe with attached needle 5ml/cc 22G x1" - 100 pcs per box, 12 box per carton
HEPRO.US INC.
CT 5ml/cc 22G x1"
In Commercial Distribution

  • 00850578007273 ()
  • 85057800727302 ()


  • General-purpose syringe, single-use

SteinerBio - 00860010170113

No Description
STEINER BIOTECHNOLOGY LLC.
SteinerBio Socket Graft 1.0 cc
In Commercial Distribution

  • 00860010170113 ()


  • Synthetic bone graft

SteinerBio - 00860010170106

No Description
STEINER BIOTECHNOLOGY LLC.
SteinerBio Socket Graft 0.5 cc
In Commercial Distribution

  • 00860010170106 ()


  • Synthetic bone graft

Dentorium - 05056079041500

Cold Cure Denture Base Powder
WRIGHT HEALTH GROUP LIMITED
Convertible CC 5kg Dark Vnd
In Commercial Distribution

  • 05056079041500 ()
2S05104

  • Denture base resin kit

Dentorium - 05056079041494

Cold Cure Denture Base Powder
WRIGHT HEALTH GROUP LIMITED
Convertible CC 3kg Dark Vnd
In Commercial Distribution

  • 05056079041494 ()
2S05304

  • Denture base resin kit

Dentorium - 05056079041487

Cold Cure Denture Base Powder
WRIGHT HEALTH GROUP LIMITED
Convertible CC 1kg Dark Vnd
In Commercial Distribution

  • 05056079041487 ()
2S05004

  • Denture base resin kit

Dentorium - 05056079041449

Cold Cure Denture Base Powder
WRIGHT HEALTH GROUP LIMITED
Convertible CC 5kg Red Vnd
In Commercial Distribution

  • 05056079041449 ()
2S05102

  • Denture base resin kit
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