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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PN841, Child Large, with Standard Elbow, Japan
Respironics, Inc.
PN841 Mask, JPN, Child Large, SE, Single Use
In Commercial Distribution

  • 00606959041592 ()
1130572

  • CPAP/BPAP nasal mask, single-use
A Series System One Heated Humidifier, Japan
Respironics, Inc.
A Series System One Heated Humidifier, JP
Not in Commercial Distribution

  • 00606959041028 ()
1111553

  • Heated respiratory humidifier
ComfortGel Blue Full Mask, Extra Large, Japan
Respironics, Inc.
ComfortGel Blue Full Mask, Extra Large, Japan
Not in Commercial Distribution

  • 00606959043909 ()
1081843

  • CPAP/BPAP face mask, reusable
BiPAP A40 Silver Series FGD SA, Japan
Respironics, Inc.
00
In Commercial Distribution

  • 00606959042797 ()
1109601

  • Portable electric ventilator
PlasmaJet Ultra Plus Console System In-Service (Japan)
PLASMA SURGICAL, INC
PS10-3130IS-JP
In Commercial Distribution

  • M397PS103130ISJP0 ()
PS10-3130IS-JP

  • Plasma surgical system
PlasmaJet V3 Plus Console System In-Service (Japan)
PLASMA SURGICAL, INC
PS10-2130IS-JP
In Commercial Distribution

  • M397PS102130ISJP0 ()
PS10-2130IS-JP

  • Plasma surgical system
ENS 97725 WIRELESS PAIN US JAPAN DEVICE
MEDTRONIC, INC.
97725
In Commercial Distribution

  • 00763000017590 ()


  • Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator
CANNULA
TSK LABORATORY, JAPAN
SGC-040050A
In Commercial Distribution

  • 14580708063383 ()
  • 04580708063386 ()
  • 04571225317519 ()

  • Outer Diameter: 0.4 Millimeter
  • Length: 50 Millimeter


  • Tissue injection cannula
CANNULA
TSK LABORATORY, JAPAN
SGC-040038A
In Commercial Distribution

  • 14580708063376 ()
  • 04580708063379 ()
  • 04571225317748 ()

  • Outer Diameter: 0.4 Millimeter
  • Length: 38 Millimeter


  • Tissue injection cannula
CANNULA
TSK LABORATORY, JAPAN
SGC-050050A
In Commercial Distribution

  • 14580708063369 ()
  • 04580708063362 ()
  • 04571225317489 ()

  • Outer Diameter: 0.5 Millimeter
  • Length: 50 Millimeter


  • Tissue injection cannula
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