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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3.3mm Diameter, 4.8mm Platform TG Implant Length 8mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG8S1
In Commercial Distribution

  • 00842448113931 ()


  • Dental implant system
3.3mm Diameter, 4.8mm Platform TG Implant Length 8mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG8R1
In Commercial Distribution

  • 00842448113924 ()


  • Dental implant system
DRUGS OF ABUSE 1
UTAK LABORATORIES, INC.
DA 1 WB VTS
In Commercial Distribution

  • B800DA1WBVTS5 ()
  • B800DA1WBVTS0 ()

  • Total Volume: 25 Milliliter
DA 1 WB VTS

  • Multiple-type clinical chemistry analyte profile IVD, control
BENZOYLECGONINE 1
UTAK LABORATORIES, INC.
BE M 1 VTS
In Commercial Distribution

  • B800BEM1VTS5 ()
  • B800BEM1VTS0 ()

  • Total Volume: 25 Milliliter
BE M 1 VTS

  • Multiple-type clinical chemistry analyte profile IVD, control
MORPHINE PLUS
UTAK LABORATORIES, INC.
MOR+ U F VTS
In Commercial Distribution

  • B800MORUFVTS5 ()
  • B800MORUFVTS0 ()

  • Total Volume: 2 Milliliter
MOR+ U F VTS

  • Multiple-type clinical chemistry analyte profile IVD, control
An iOS mobile application used to adjust Sonify Hearing wireless OTC hearing aids.
Novidan, Inc.
99-0011-08
In Commercial Distribution

  • 00850049194037 ()


  • Air-conduction hearing aid, receiver-in-canal
An iOS platform mobile application used to adjust NoviMed wireless OTC hearing aids.
Novidan, Inc.
99-0011-10
In Commercial Distribution

  • 00850049194013 ()


  • Air-conduction hearing aid, receiver-in-canal
TG Ab QC Kit - Atellica IM - CLT 2 x 3 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995465
In Commercial Distribution

  • 00630414597928 ()
10995465

  • Thyroglobulin antibody IVD, control
TG Ab - Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995464
In Commercial Distribution

  • 00630414597911 ()
10995464

  • Thyroglobulin antibody IVD, control
Care Assist
Philips Medizin Systeme Böblingen GmbH
Care Assist iOS
In Commercial Distribution

  • 00884838127432 ()
989803221531

  • Centralized patient monitor
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