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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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BioCera Fibers is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phosphate, siloxane-containing vaterite (a form of calcium carbonate), and poly(L-lactide co glycolide). The electrospinning process used in manufacturing BioCera Fibers results in a cotton-like physical form. Due to its physical form, BioCera Fibers is flexible and can easily fill defects in appropriate amounts.
ORTHOREBIRTH CO.,LTD.
0.4g
In Commercial Distribution

  • 04573190050538 ()

  • Total Volume: 4 Milliliter
ORB-0304C-KC

  • Synthetic bone graft
BioCera Fibers is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phosphate, siloxane-containing vaterite (a form of calcium carbonate), and poly(L-lactide co glycolide). The electrospinning process used in manufacturing BioCera Fibers results in a cotton-like physical form. Due to its physical form, BioCera Fibers is flexible and can easily fill defects in appropriate amounts.
ORTHOREBIRTH CO.,LTD.
1.0g
In Commercial Distribution

  • 04573190050521 ()

  • Total Volume: 10 Milliliter
ORB-0310C-KC

  • Synthetic bone graft
BioCera Fibers is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phosphate, siloxane-containing vaterite (a form of calcium carbonate), and poly(L-lactide co glycolide). The electrospinning process used in manufacturing BioCera Fibers results in a cotton-like physical form. Due to its physical form, BioCera Fibers is flexible and can easily fill defects in appropriate amounts.
ORTHOREBIRTH CO.,LTD.
2.0g
In Commercial Distribution

  • 04573190050514 ()

  • Total Volume: 20 Milliliter
ORB-0320C-KC

  • Synthetic bone graft
ReBOSSIS QDS is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phosphate, siloxane-containing vaterite (a form of calcium carbonate), and poly(L-lactide co glycolide). The electrospinning process used in manufacturing ReBOSSIS QDS results in a cotton-like physical form. Due to its physical form, ReBOSSIS QDS is flexible and can easily fill defects in appropriate amounts.
ORTHOREBIRTH CO.,LTD.
0.25g
In Commercial Distribution

  • 04573190050361 ()

  • Total Volume: 2 Milliliter
ORB-0305D

  • Synthetic bone graft
ReBOSSIS QDS is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phosphate, siloxane-containing vaterite (a form of calcium carbonate), and poly(L-lactide co glycolide). The electrospinning process used in manufacturing ReBOSSIS QDS results in a cotton-like physical form. Due to its physical form, ReBOSSIS QDS is flexible and can easily fill defects in appropriate amounts.
ORTHOREBIRTH CO.,LTD.
0.5g
Not in Commercial Distribution

  • 04573190050354 ()

  • Total Volume: 4 Milliliter
ORB-0305D

  • Synthetic bone graft
The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration
Inspire Medical Systems, Inc.
900-002-007
In Commercial Distribution

  • 00855728005192 ()
4323

  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration.
Inspire Medical Systems, Inc.
900-002-005
In Commercial Distribution

  • 00855728005000 ()
4323

  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Amsel Occluder Device is designed to easily and securely close blood vessels (veins or arteries as well as hollow ducts) during surgical procedures. It is intended for use in open general surgery procedures on tubular structures or blood vessels (arteries and veins) wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.
AMSEL MEDICAL CORPORATION
100-200
In Commercial Distribution

  • 00857774006000 ()
  • 10857774006007 ()
  • 20857774006004 ()
  • 30857774006001 ()
100-200

  • Ligation clip, metallic
The ATHLET VBR System is a lordotic, modular vertebral body replacement system. Caudal and cranial components are offered in a variety of heights and are assembled to create a device construct. An intermediate component is also available and is used between one caudal and one cranial component. The device construct comprises a central cannula for bone graft and lateral fenestrations for bony in-growth.
SIGNUS Medizintechnik GmbH
Connection screw
In Commercial Distribution

  • 04047844002414 ()

  • Ø3x9mm
ATM309

  • Spinal fixation plate, non-bioabsorbable
The ATHLET VBR System is a lordotic, modular vertebral body replacement system. Caudal and cranial components are offered in a variety of heights and are assembled to create a device construct. An intermediate component is also available and is used between one caudal and one cranial component. The device construct comprises a central cannula for bone graft and lateral fenestrations for bony in-growth.
SIGNUS Medizintechnik GmbH
Main body 8
In Commercial Distribution

  • 04047844002391 ()

  • 36x14x15mm
AT0836

  • Vertebral body prosthesis
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