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
VDW GmbH
V841119000515
In Commercial Distribution

  • E225V8411190005150 ()
  • E225V8411190005151 ()
V841119000515

  • Endodontic apex locator
No Description
VDW GmbH
V841113000000
In Commercial Distribution

  • E225V8411130000001 ()
  • E225V8411130000000 ()
V841113000000

  • Endodontic apex locator
PCP25
PREMIER BIOTECH, INC
PBCard-01-PCP
In Commercial Distribution

  • B313PBCARD01PCP1 ()
  • B313PBCARD01PCP0 ()
PBCard-01-PCP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
USP Sterile Water, 100 mL Bottle
NURSE ASSIST, INC.
6492776
In Commercial Distribution

  • B15064927764 ()
  • B15064927760 ()


  • Wound irrigation sterile water
USP Normal Saline, 100 mL Bottle
NURSE ASSIST, INC.
6492775
In Commercial Distribution

  • B15064927750 ()
  • B15064927754 ()


  • Non-antimicrobial wound irrigation solution, saline
Implant Caddy II, Fixcet
Xtant Medical Holdings, Inc.
X063-1003
In Commercial Distribution

  • M697X06310030 ()
  • M697X06310031 ()


  • Device sterilization/disinfection container, reusable
Sterilization Case II, Fixcet
Xtant Medical Holdings, Inc.
X063-1002
In Commercial Distribution

  • M697X06310020 ()
  • M697X06310021 ()


  • Device sterilization/disinfection container, reusable
Fixcet Spinal Facet Screw Set II
Xtant Medical Holdings, Inc.
X063-1000
In Commercial Distribution

  • M697X06310000 ()
  • M697X06310001 ()


  • Trans-facet-screw internal spinal fixation system, sterile
Blunt K-wire Holder
Xtant Medical Holdings, Inc.
X063-0087
In Commercial Distribution

  • M697X06300870 ()
  • M697X06300871 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
K-wire Holder, Cradle
Xtant Medical Holdings, Inc.
X063-0085
In Commercial Distribution

  • M697X06300850 ()
  • M697X06300851 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
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