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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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No Description
Orasure Technologies, Inc.
1124EB
In Commercial Distribution

  • 00608337000399 ()


  • Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)
Surgical Instrument Tray
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
33509
In Commercial Distribution

  • 09008737335090 ()


  • Instrument tray, reusable
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
1937S
In Commercial Distribution

  • 10842430110112 ()
  • 00842430110115 ()
1937SDZ

  • Freestanding headrest, single-use
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
1941S
In Commercial Distribution

  • 10842430110099 ()
  • 00842430110092 ()
1941SDZ

  • Freestanding headrest, single-use
No Description
BIOCARE MEDICAL LLC
ALI105G7
In Commercial Distribution

  • 00847627029751 ()


  • Cytokeratin IVD, antibody
No Description
ATOM MEDICAL CORPORATION
60321
In Commercial Distribution

  • 04942962603218 ()
  • 84942962603214 ()
60321

  • Basic bed sheet, single-use
I-GEL SUPRAGLOTTIC AIRWAY, SIZE 5
Intersurgical Incorporated
8205000
In Commercial Distribution

  • 05030267047079 ()
  • 05030267073702 ()


  • Laryngeal mask airway, single-use
Multidil 5Readypack (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10309946
Not in Commercial Distribution

  • 00630414175263 ()
  • 00630414003122 ()
110317

  • Buffered sample diluent IVD
Self-Adhesive Polyurethane Dressing
SMITH & NEPHEW MEDICAL LIMITED
66047578
In Commercial Distribution

  • 05000223452926 ()
  • 05000223452919 ()
  • 05000223452933 ()
66047578

  • Exudate-absorbent dressing, non-gel, non-antimicrobial
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
1600690-001
In Commercial Distribution

  • J00716006900011 ()
1600690-001

  • Dental power tool system handpiece, remotely-driven
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