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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 Class Implantable

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Carotid Sinus Lead Repair Kit
CVRX, INC.
5010
In Commercial Distribution

  • 00859144004203 ()
100056-301

  • Baroreceptor electrical stimulation system
Programmer System
CVRX, INC.
9010
In Commercial Distribution

  • 00859144004128 ()
100055-102

  • Baroreceptor electrical stimulation system
StitchKit® PR Suture and Needle Management Device
ORIGAMI SURGICAL LLC
SK-105
In Commercial Distribution

  • 00860004977339 ()
  • 10860004977336 ()


  • Polyester suture, bioabsorbable, multifilament, non-antimicrobial
  • Barbed polyester suture, non-antimicrobial
StitchKit® EC Suture and Needle Management Device
ORIGAMI SURGICAL LLC
SK-108
In Commercial Distribution

  • 00860004977322 ()
  • 10860004977329 ()


  • Polyester suture, bioabsorbable, multifilament, non-antimicrobial
  • Barbed polyester suture, non-antimicrobial
StitchKit® BA Suture and Needle Management Device
ORIGAMI SURGICAL LLC
SK-103
In Commercial Distribution

  • 10860004977305 ()
  • 00860004977308 ()


  • Polyester suture, bioabsorbable, multifilament, non-antimicrobial
  • Barbed polyester suture, non-antimicrobial
StitchKit® URO Suture and Needle Management Device
ORIGAMI SURGICAL LLC
SK-110
In Commercial Distribution

  • 10860004977381 ()
  • 00860004977384 ()


  • Polyester suture, bioabsorbable, multifilament, non-antimicrobial
  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
StitchKit® RNY Suture and Needle Management Device
ORIGAMI SURGICAL LLC
SK-109
In Commercial Distribution

  • 10860004977374 ()
  • 00860004977377 ()


  • Polyester suture, bioabsorbable, multifilament, non-antimicrobial
  • Barbed polyester suture, non-antimicrobial
StitchKit® RHP Suture and Needle Management Device
ORIGAMI SURGICAL LLC
SK-107
In Commercial Distribution

  • 00860004977353 ()
  • 10860004977350 ()


  • Polyester suture, bioabsorbable, multifilament, non-antimicrobial
  • Barbed polyester suture, non-antimicrobial
StitchKit® PTFE Suture and Needle Management Device
ORIGAMI SURGICAL LLC
VH-PC
In Commercial Distribution

  • 00860088000237 ()
  • 10860088000234 ()


  • Polyolefin/fluoropolymer suture, monofilament
StitchKit® HE Suture and Needle Management Device
ORIGAMI SURGICAL LLC
SK-104
In Commercial Distribution

  • 10860004977312 ()
  • 00860004977315 ()


  • Polyester suture, bioabsorbable, multifilament, non-antimicrobial
  • Barbed polyester suture, non-antimicrobial
  • Silk suture
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