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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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Handheld Single-use Surgical Nerve Stimulator
Checkpoint Surgical, Inc.
9095
In Commercial Distribution

  • B13090951 ()
  • B13090950 ()
  • B13090952 ()
  • B13090953 ()
9095

  • Nerve-locating system
Handheld Single-use Surgical Bipolar Nerve Stimulator
Checkpoint Surgical, Inc.
9092
In Commercial Distribution

  • B13090921 ()
  • B13090920 ()
  • B13090922 ()
  • B13090923 ()
9092

  • Nerve-locating system
ProVeil™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. ProVeil™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries.
Checkpoint Surgical, Inc.
PV4030
In Commercial Distribution

  • B130PV40301 ()
  • B130PV40300 ()
  • B130PV40302 ()
  • B130PV40303 ()
PV4030

  • Nerve guide, animal-derived
1lb. TriPhasix™ Chromatic Alginate
PARKELL, INC.
S400
Not in Commercial Distribution

  • M595S4043 ()
  • M595S4000 ()
  • M595S4022 ()
  • M595S4011 ()
S400

  • Silicone dental impression material
Instrument Jaw Covers, Multi-Color Pack
AXIOM MEDICAL, INCORPORATED
301
In Commercial Distribution

  • M6653013 ()
  • M6653011 ()
  • M6653010 ()
  • M6653015 ()


  • Vascular booties
Instrument Jaw Covers, White
AXIOM MEDICAL, INCORPORATED
300
In Commercial Distribution

  • M6653003 ()
  • M6653001 ()
  • M6653000 ()
  • M6653005 ()


  • Vascular booties
Retraction Tape, Mini, Blue, Veins
AXIOM MEDICAL, INCORPORATED
118
In Commercial Distribution

  • M6651185 ()
  • M6651183 ()
  • M6651181 ()
  • M6651180 ()


  • Surgical support tape, non-bioabsorbable
Retraction Tape, Mini, Yellow, Ureters
AXIOM MEDICAL, INCORPORATED
116
In Commercial Distribution

  • M6651165 ()
  • M6651163 ()
  • M6651161 ()
  • M6651160 ()


  • Surgical support tape, non-bioabsorbable
Retraction Tape, Maxi, White, Nerves
AXIOM MEDICAL, INCORPORATED
113
In Commercial Distribution

  • M6651135 ()
  • M6651133 ()
  • M6651131 ()
  • M6651130 ()


  • Surgical support tape, non-bioabsorbable
MAG1-2030: 20cm x 30cm (8in x 12in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-2030
In Commercial Distribution

  • MDLXMAG120300 ()
  • MDLXMAG120303 ()
  • MDLXMAG120302 ()
  • MDLXMAG120301 ()
MAG1-2030

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
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