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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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BOJRAB DISSECTOR, LARGE, ANGLED 20° 2.2MM x 2.0MM, L 165MM
Grace Medical, Inc.
999-DB1
In Commercial Distribution

  • 00844505009645 ()


  • Open-surgery dissector
A Qualitative Immunoassay for the Detection of Human Chorionic Gonadotropin (hCG) in Urine.
STANBIO LABORATORY, L.P.
1430-003
In Commercial Distribution

  • 00657498002063 ()
  • 00657498002070 ()
1430-003

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
A Qualitative Immunoassay for the Detection of Human Chorionic Gonadotropin (hCG) in Serum or Urine.
STANBIO LABORATORY, L.P.
1440-025
In Commercial Distribution

  • 00657498001400 ()
  • 00657498001417 ()
1440-025

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Ref. 1457
Ambu A/S
814900-125
Not in Commercial Distribution

  • 05707480042104 ()
  • 05707480097043 ()
814900-125

  • Polysomnograph
A Qualitative Immunoassay for the Detection of Human Chorionic Gonadotropin (hCG) in Serum or Urine.
STANBIO LABORATORY, L.P.
1440-050
In Commercial Distribution

  • 00657498001370 ()
  • 00657498001387 ()
1440-050

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
No Description
OXOID LIMITED
MB1128A
In Commercial Distribution

  • 05032384127498 ()


  • Multiple bacteria species culture isolate identification control IVD, kit
No Description
OXOID LIMITED
CD0020C
In Commercial Distribution

  • 05032384123261 ()


  • Atmospheric generation kit IVD
No Description
OXOID LIMITED
CN0020C
In Commercial Distribution

  • 05032384034611 ()


  • Atmospheric generation kit IVD
Sets of Chiropro systems and their dental micromotors or contra-angles plus relevant accessories
Bien-Air Dental SA
1700388-001
In Commercial Distribution

  • J00717003880011 ()
1700388-001

  • Surgical power tool system control unit, line-powered
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600785-001
In Commercial Distribution

  • J00716007850011 ()
1600785-001

  • Dental power tool system handpiece, remotely-driven
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