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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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StitchKit - 00860004977322

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 - 00860004977308

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

Dymaxeon - 00815500025008

DYMAXEON SPONDYLOLISTHESIS PEDICLE SCREW - CAP INCLUDED SIZE Ø6.5 x 60mm (GREEN)
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500025008 ()
06.3860B-1

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon - 00815500024476

DYMAXEON PEDICLE SCREW - CANNULATED - CAP INCLUDED Ø7.5 x 35mm (VIOLET)
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500024476 ()
06.6600B-1

  • Bone-screw internal spinal fixation system, sterile

SYSTANE - 00300650190930

SYSTANE Contacts Lubricant Eye Drops 12ml
Alcon Laboratories, Inc.
SYSTANE 12ml
In Commercial Distribution

  • 00300650190930 ()
  • 20300650190934 ()


  • Contact lens wetting solution
  • Eye lubricant

StitchKit - 00860004977315

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

StitchKit - 00860004977346

StitchKit® RSCP Suture and Needle Management Device
ORIGAMI SURGICAL LLC
SK-106
In Commercial Distribution

  • 00860004977346 ()
  • 10860004977343 ()


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
  • Polyolefin/fluoropolymer suture, monofilament

Clear Guide TipTAG - B201CGTT0

No Description
CLEAR GUIDE MEDICAL, INC.
CGTT
In Commercial Distribution

  • B201CGTT1 ()
  • B201CGTT0 ()
  • B201CGTT2 ()


  • Imaging lesion localization marker, external, single-use
  • Surgical optical-tracking spatial marker, single-use

MotoBAND - 00815432027798

The MotoBAND™ CP Implant System is a bone plating system indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. It consist of plates and screws.
CROSSROADS EXTREMITY SYSTEMS
H10 Self Retaining Driver
In Commercial Distribution

  • 00815432027798 ()
1500-5050

  • Surgical screwdriver, single-use
  • Surgical screwdriver, reusable

MotoBAND - 00815432026012

The MotoBAND™ CP Implant System is a bone plating system indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. It consist of plates and screws.
CROSSROADS EXTREMITY SYSTEMS
MotoBAND CP, H10 Non-Retaining Driver
In Commercial Distribution

  • 00815432026012 ()
1500-5030

  • Surgical screwdriver, reusable
  • Surgical screwdriver, single-use
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