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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ComfortGel Blue Full Mask, Small, Japan
Respironics, Inc.
ComfortGel Blue Full Mask, Small, Japan
Not in Commercial Distribution

  • 00606959043879 ()
1081840

  • CPAP/BPAP face mask, reusable
PlasmaJet Ultra Plus Console System (Japan)
PLASMA SURGICAL, INC
PS10-3130-JP
In Commercial Distribution

  • M397PS103130JP0 ()
PS10-3130-JP

  • Plasma surgical system
ACMF JAPAN A PACK BLUE 25
O&M HALYARD, INC.
77509
In Commercial Distribution

  • 20680651775096 ()
  • 30680651775093 ()


  • General surgical procedure kit, non-medicated, single-use
Universal Base, Japan Implant Case Small
Nuvasive, Inc.
7241004
In Commercial Distribution

  • 00887517061522 ()


  • Device sterilization/disinfection container, reusable
PlasmaJet V3 Plus Console System (Japan)
PLASMA SURGICAL, INC
PS10-2130-JP
In Commercial Distribution

  • M397PS102130JP0 ()
PS10-2130-JP

  • Plasma surgical system
Digitest™ II Digital Pulptester (Japan)
PARKELL, INC.
D640E-JM
In Commercial Distribution

  • 00810000520657 ()
D640E-JM

  • Dental pulp analysis system
4000 RESPIRATORY MONITOR COPD-6 JAPAN HI-CHECKER
VITALOGRAPH (IRELAND) LIMITED
4000
In Commercial Distribution

  • 05099169402638 ()
  • 15099169402635 ()
  • 35099169402639 ()


  • Expiratory peak flow meter, digital
Precision Systems OSMETTE XL osmometer, 105VAC, Japan
Precision Systems, Inc.
5007J
In Commercial Distribution

  • 00850041049199 ()
5007J

  • Osmometric analyser IVD
FINAL ASSEMBLY, SPARK™ TRUCOLOR, TTL, JAPAN
METREX RESEARCH, LLC
910174-11
In Commercial Distribution

  • 00615375013250 ()


  • Surgical binoculars, reusable
ASSY, LTV1150, W/ ACC, GREY BTS, JAPAN
Carefusion Corporation
27552-006
Not in Commercial Distribution

  • 00845873004911 ()


  • Transport electric ventilator
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