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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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Oxford® - 00887868485534

No Description
Biomet Orthopedics, LLC
32-423335
In Commercial Distribution

  • 00887868485534 ()

  • Size E
32-423335

  • Surgical implant template, reusable

Arcos® Modular Revision System - 00887868466649

No Description
Biomet Orthopedics, LLC
110018392
In Commercial Distribution

  • 00887868466649 ()

  • Size E
110018392

  • Bone-resection orthopaedic reamer, reusable

Stool Bacterial Pathogens Panel - B178GBSBPP100

Stool Bacterial Pathogens Panel Cartridge with sample prep device.
GREAT BASIN SCIENTIFIC, INC.
GBSBPP-10
In Commercial Distribution

  • B178SBPP102 ()
  • B178GBSBPP100 ()
GBSBPP-10

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

E 3-12 - 08056304453891

No Description
ESAOTE SPA
120000038
In Commercial Distribution

  • 08056304453891 ()


  • Extracorporeal ultrasound imaging transducer, hand-held

Synergy E - B036101483

Synergy E Host Software for SmartMonitor 2 Product Line
CIRCADIANCE, LLC
101483
In Commercial Distribution

  • B036101483 ()
101483

  • Infant apnoea monitor

E- Handle - 10812269022658

E-Handle, AO, Black
MIAMI DEVICE SOLUTIONS LLC
MDS000606AO
In Commercial Distribution

  • 10812269022658 ()
MDS000606AO

  • Surgical instrument handle, non-torque-limiting
  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

AMC&E - 10817357021247

AMC&E 5-Lead Grouped Set, Pinch (Grabber) to Multi-Link® Shielded Disposable, 50in.
HYGIA HEALTH SERVICES, INC.
LW-341DS50/5A
Not in Commercial Distribution

  • 30817357021241 ()
  • 10817357021247 ()


  • Electrocardiographic lead set, reprocessed

AMC&E - 10817357020837

AMC&E 5-lead DIN to Pinch Telemetry Leadset
HYGIA HEALTH SERVICES, INC.
LW-309DS50/5AT
Not in Commercial Distribution

  • 30817357020831 ()
  • 10817357020837 ()


  • Electrocardiographic lead set, reprocessed

AMC&E - 10817357020578

AMC&E 3-lead DIN to Pinch Leadset
HYGIA HEALTH SERVICES, INC.
LW-309DS50/3A
Not in Commercial Distribution

  • 30817357020572 ()
  • 10817357020578 ()


  • Electrocardiographic lead set, reprocessed

AMC&E - 10817357020486

AMC&E 5-lead DIN to Pinch Leadset
HYGIA HEALTH SERVICES, INC.
LW-309DS50/5A
Not in Commercial Distribution

  • 30817357020480 ()
  • 10817357020486 ()


  • Electrocardiographic lead set, reprocessed
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