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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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PREMIUM ONE IMPLANT ZIRTI D.4.25 H.10 MM
SWEDEN & MARTINA SPA
AS-ZT-425-100
In Commercial Distribution

  • D7701304643 ()
AS-ZT-425-100

  • Screw endosteal dental implant, two-piece
PREMIUM ONE IMPLANT ZIRTI D.4.25 H.8.5 MM
SWEDEN & MARTINA SPA
AS-ZT-425-085
In Commercial Distribution

  • D7701304633 ()
AS-ZT-425-085

  • Screw endosteal dental implant, two-piece
PREMIUM ONE IMPLANT ZIRTI D.4.25 H.7 MM
SWEDEN & MARTINA SPA
AS-ZT-425-070
In Commercial Distribution

  • D7701304623 ()
AS-ZT-425-070

  • Screw endosteal dental implant, two-piece
No Description
UNIVERSAL MEDITECH INC.
21001
In Commercial Distribution

  • B512210011 ()
210-01

  • Follicle stimulating hormone (FSH) IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
No Description
UNIVERSAL MEDITECH INC.
20001
In Commercial Distribution

  • B512200011 ()
200-01

  • Natural conception assistance kit
No Description
UNIVERSAL MEDITECH INC.
10001
In Commercial Distribution

  • B512100011 ()
100-01

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
The Zeto ONE Head Unit is a detachable part of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The Head Unit component of the Zeto ONE is intended to hold electrodes on the subject's scalp and aquire electric signals produced by human brain activity.
ZETO INC
ZP-120-11011
In Commercial Distribution

  • B675ONEHU1 ()

  • Regular
  • Small


  • Electroencephalograph
Latex Lubricated Condoms
GLOBAL PROTECTION CORP.
MY-S343
In Commercial Distribution

  • 20726893118151 ()
  • 00726893118157 ()
  • 80726893118153 ()


  • Basic male condom, Hevea-latex
Latex Lubricated Condom
GLOBAL PROTECTION CORP.
MY-S323
In Commercial Distribution

  • 20726893118144 ()
  • 00726893118140 ()
  • 80726893118146 ()


  • Basic male condom, Hevea-latex
Latex Lubricated condom- Sampler kit
GLOBAL PROTECTION CORP.
MY-S303
In Commercial Distribution

  • 20726893118137 ()
  • 00726893118133 ()
  • 80726893118139 ()


  • Basic male condom, Hevea-latex
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