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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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BonOs R Genta 1x40 - 04260056885679

BonOs® R Genta is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. BonOs® R Genta cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. BonOs® R Genta does not emit a signal and does not pose a safety risk in a magnetic resonance environment.
OSARTIS GmbH
01-0217
In Commercial Distribution

  • 14260056885676 ()
  • 04260056885679 ()

  • Weight: 40.8 Gram


  • Orthopaedic cement, antimicrobial

BonOs R 1x40 - 04260056885624

BonOs® R is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. BonOs® R cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. BonOs® R does not emit a signal and does not pose a safety risk in a magnetic resonance environment.
OSARTIS GmbH
01-0117
In Commercial Distribution

  • 14260056885621 ()
  • 04260056885624 ()

  • Weight: 40 Gram


  • Orthopaedic cement, non-antimicrobial

BonOs Inject - 04260056883231

BonOs® Inject is a radiopaque, injectable bone cement for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using vertebroplasty or balloon kyphoplasty procedure. When used in conjunction with NEO Pedicle Screw System™ BonOs® Inject is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised. Mixing the two separate sterile components initially produces a ductile, injectable bone cement which, after hardening in situ, is able to stabilize neoplastic vertebral lesions and vertebral compression fractures. BonOs® Inject cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium.
OSARTIS GmbH
01-0309
In Commercial Distribution

  • 04260056883231 ()
  • 14260056883238 ()

  • Weight: 24 Gram


  • Vertebral bone filler, non-bioabsorbable

BonOs HV Genta - 04260056882623

BonOs® HV Genta is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. BonOs® HV Genta cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. BonOs® HV Genta does not emit a signal and does not pose a safety risk in a magnetic resonance environment.
OSARTIS GmbH
1x40
In Commercial Distribution

  • 04260056882623 ()
  • 14260056882620 ()

  • Weight: 40.8 Gram
01-0262

  • Orthopaedic cement, antimicrobial

BonOs HV - 04260056882579

BonOs® HV is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant. BonOs® HV cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. BonOs® HV does not emit a signal and does not pose a safety risk in a magnetic resonance environment.
OSARTIS GmbH
1x40
In Commercial Distribution

  • 04260056882579 ()

  • Weight: 40 Gram
01-0162

  • Orthopaedic cement, non-antimicrobial

Vertecem II Cement Kit - 04260056880759

Vertecem II is a radio-opaque, injectable acrylic bone cement used for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a Vertebroplasty or Kyphoplasty procedure.
OSARTIS GmbH
08.702.017S
In Commercial Distribution

  • 04260056880759 ()
  • 14260056880756 ()

  • Weight: 22 Gram
08.702.017S

  • Vertebral bone filler, non-bioabsorbable

Sterilization Wrap, Economy, Blue - 00841982100346

WL11395D, Sterilization Wrap, Economy, Blue, 24 x 24 inches [] 500 sheets/case, 2 sheets per application = 250 applications
AHLSTROM NONWOVENS LLC
WL1139524
In Commercial Distribution

  • 00841982100346 ()
  • 00841982100650 ()


  • Sterilization packaging, single-use

Sterilization Wrap, Robust, Blue - 00841982100193

WL09929D, Sterilization Wrap, Robust, Blue, 24 x 24 inches [] 400 sheets/case, 2 sheets per application = 200 applications
AHLSTROM NONWOVENS LLC
WL0992924
In Commercial Distribution

  • 00841982100193 ()
  • 00841982100568 ()


  • Sterilization packaging, single-use

StimChoice OTC Electrodes - 00092237622148

StimChoice OTC Snap Electrodes - White Cloth, Hand, 24/pk Includes (24) 2" x 4" hand shaped snap electrodes
COMPASS HEALTH BRANDS CORP.
E20H-24A
In Commercial Distribution

  • 80092237622144 ()
  • 00092237622148 ()
  • 30092237622149 ()
  • 01092237622147 ()


  • Transcutaneous electrical stimulation electrode, single-use

0 Ppn Uni 30cm - 00848782020553

0 Ppn Uni 30cm
Surgical Specialties México, S. de R.L. de C.V.
VLO-1001
In Commercial Distribution

  • 10848782020550 ()
  • 00848782020553 ()

  • 0 USP


  • Polyolefin/fluoropolymer suture, monofilament
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