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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XiVE® TG Gold Bar Coping with Guide Pin
Dentsply Implants Manufacturing GmbH
32254240
Not in Commercial Distribution

  • EFRI322542402 ()
25-4240

  • Dental implant suprastructure, permanent, preformed
XiVE® TG Titanium Bar Coping with Guide Pin
Dentsply Implants Manufacturing GmbH
32254241
Not in Commercial Distribution

25-4241

  • Dental implant suprastructure, permanent, preformed
XiVE® TG Gold Bar Coping with Guide Pin
Dentsply Implants Manufacturing GmbH
32254240
Not in Commercial Distribution

25-4240

  • Dental implant suprastructure, permanent, preformed
Mix2Vial™ 20/20mm w/15µm Large Filter TG
WEST PHARMA. SERVICES IL, . LTD
8074046
In Commercial Distribution

  • 27290108240997 ()
  • 17290108240990 ()
  • 07290108240993 ()


  • Medication transfer needle, filtering
VA 20mm FLL SIL w/25μm Filter TG - VF
WEST PHARMA. SERVICES IL, . LTD
8072114
In Commercial Distribution

  • 27290108240669 ()
  • 17290108240662 ()
  • 07290108240665 ()


  • Vial/bottle adaptor, non-hermetic
Mix2Vial 20/20mm W/20mic large filter TG S-Spike
WEST PHARMA. SERVICES IL, . LTD
8074022
In Commercial Distribution

  • 27290108240423 ()
  • 17290108240426 ()
  • 07290108240429 ()


  • Medication transfer needle, filtering
Vial Adapter 20mm ML TG SS Blue SIL- VF
WEST PHARMA. SERVICES IL, . LTD
8072028
Not in Commercial Distribution

  • 27290108240003 ()
  • 17290108240006 ()
  • 07290108240009 ()


  • Vial/bottle adaptor, non-hermetic
No Description
Philips Ultrasound LLC
795161
In Commercial Distribution

  • 00884838103405 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
No Description
Sugarmate, LLC
1007228
In Commercial Distribution

  • 00850018992435 ()


  • Self-care monitoring/reporting software
Clinical decision support software indicated for use by licensed clinicians to inform the detection of disease utilizing an iOS client.
AMBIENT CLINICAL ANALYTICS, INC.
1.0
In Commercial Distribution

  • 00850893007033 ()


  • Clinical management support software
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