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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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InnoVoyce Laser Fiber .600 1 Pack RFID
Innovoyce LLC
B
In Commercial Distribution

  • 00860011812173 ()
  • 00860011812142 ()
I0128-ASY-300063-600

  • General/multiple surgical laser system beam guide, single-use
InnoVoyce Laser Fiber .400 1 Pack RFID
Innovoyce LLC
B
In Commercial Distribution

  • 00860011812166 ()
  • 00860011812135 ()
I0128-ASY-300063-400

  • General/multiple surgical laser system beam guide, single-use
InnoVoyce Laser Fiber .300 1 Pack RFID
Innovoyce LLC
B
In Commercial Distribution

  • 00860011812159 ()
  • 00860011812128 ()
I0128-ASY-300063-300

  • General/multiple surgical laser system beam guide, single-use
No Description
Chartwell Rx, LLC
3 mL
In Commercial Distribution

  • 00860011790310 ()
  • 00860011790303 ()
  • 00860011790327 ()
REF 62135-832-84

  • Inhalation therapy saline solution, isotonic
AURA™ Holster
Branchpoint & Aura Development LLC
SP104
In Commercial Distribution

  • 00860011785293 ()
SP104

  • Removable ambulatory appliance skin-adherent patch
AURA™ Sensor & Holster
Branchpoint & Aura Development LLC
SP103
In Commercial Distribution

  • 00860011785286 ()
SP103

  • Intracerebral sensor catheter, short-term
AURA™ Sensor
Branchpoint & Aura Development LLC
SP102
In Commercial Distribution

  • 00860011785279 ()
SP102

  • Intracerebral sensor catheter, short-term
AURA™ Sensor Tray
Branchpoint & Aura Development LLC
SP101
In Commercial Distribution

  • 00860011785200 ()
SP101

  • Intracerebral sensor catheter, short-term
Watson Flex Retractor System SQ-170
BIOPHYX LLC
10010
In Commercial Distribution

  • 00860011767909 ()


  • Self-retaining surgical retractor, single-use
Breast Implant Removal Device, 2 Pack
Gaylord Solutions LLC
EMD0003
In Commercial Distribution

  • 00860011750215 ()
  • 00860011750222 ()
EMD0003

  • General-purpose surgical suction system, vacuum
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