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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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primaLOK SP 10mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as ack pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0110-00
In Commercial Distribution

  • 00813210021747 ()

  • Height: 10 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
primaLOK SP 8mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0108-00
In Commercial Distribution

  • 00813210021730 ()

  • Height: 8 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
primaLOK SP 6mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0106-00
In Commercial Distribution

  • 00813210021723 ()

  • Height: 6 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters
TELEFLEX INCORPORATED
IPN032649
In Commercial Distribution

  • 20801902001270 ()
  • 10801902001273 ()
AK-09903-J

  • Arterial blood pressure catheter
Cover lashes, lids, and brow for ophthalmic surgery, or office procedures. Adhesive area 12.7 x 18.4 cm.
HURRICANE MEDICAL INC
9701
In Commercial Distribution

  • 10813465012191 ()
  • 00813465012194 ()

  • Length: 22.8 Centimeter
  • Width: 12.7 Centimeter
9701

  • Hypoallergenic skin adhesive tape
Peripheral Polyaxial Compression/Locking Screws is a superior and Inferior compression with caps for subsequent locking option.
Ascension Orthopedics, Inc.
SSC096004550
In Commercial Distribution

  • 10381780121770 ()
  • M269SSC0960045501 ()

  • 53 mm L x 4.5 mm dia
SSC-0960-045-50

  • Orthopaedic bone screw, non-bioabsorbable, sterile
Peripheral Polyaxial Compression/Locking Screws is a superior and Inferior compression with caps for subsequent locking option.
Ascension Orthopedics, Inc.
SSC096004545
In Commercial Distribution

  • 10381780121763 ()
  • M269SSC0960045451 ()

  • 48 mm L x 4.5 mm dia
SSC-0960-045-45

  • Orthopaedic bone screw, non-bioabsorbable, sterile
Peripheral Polyaxial Compression/Locking Screws is a superior and Inferior compression with caps for subsequent locking option.
Ascension Orthopedics, Inc.
SSC096004540
In Commercial Distribution

  • 10381780121756 ()
  • M269SSC0960045401 ()

  • 43 mm L x 4.5 mm dia
SSC-0960-045-40

  • Orthopaedic bone screw, non-bioabsorbable, sterile
Peripheral Polyaxial Compression/Locking Screws is a superior and Inferior compression with caps for subsequent locking option.
Ascension Orthopedics, Inc.
SSC096004535
In Commercial Distribution

  • 10381780121749 ()
  • M269SSC0960045351 ()

  • 38 mm L x 4.5 mm dia
SSC-0960-045-35

  • Orthopaedic bone screw, non-bioabsorbable, sterile
Peripheral Polyaxial Compression/Locking Screws is a superior and Inferior compression with caps for subsequent locking option.
Ascension Orthopedics, Inc.
SSC096004530
In Commercial Distribution

  • 10381780121732 ()
  • M269SSC0960045301 ()

  • 33 mm L x 4.5 mm dia
SSC-0960-045-30

  • Orthopaedic bone screw, non-bioabsorbable, sterile
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