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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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HA PEEK, Ta
Innovasis, Inc.
LXL18084508
In Commercial Distribution

  • M711LXL180845081 ()
  • M711LXL180845080 ()

  • Width: 18 Millimeter
  • Height: 8 Millimeter
  • Length: 45 Millimeter
  • Angle: 8 degree
LXL18084508

  • Polymeric spinal interbody fusion cage
HA PEEK, Ta
Innovasis, Inc.
LXL18084500
In Commercial Distribution

  • M711LXL180845001 ()
  • M711LXL180845000 ()

  • Angle: 0 degree
  • Length: 45 Millimeter
  • Height: 8 Millimeter
  • Width: 18 Millimeter
LXL18084500

  • Polymeric spinal interbody fusion cage
Sterilized Electric Screw Driver, Cranial, Plastic, electronics, SST
Innovasis, Inc.
LS-572
In Commercial Distribution

  • M711LS5720 ()
  • M711LS5721 ()


  • Orthopaedic implant driver
The RICHPLAT ORTHO™ Platelet Rich Plasma System is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood at the patient’s point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.
FIDIA FARMACEUTICI SPA
FPRP20
In Commercial Distribution

  • M713FPRP200 ()
  • M713FPRP201 ()
FPRP20

  • Haematological concentrate system preparation kit, platelet concentration
Ti 6Al 4V (ELI); Hydroxyapatite
Innovasis, Inc.
TXT12163312
In Commercial Distribution

  • M711TXT121633121 ()
  • M711TXT121633120 ()

  • Width: 12 Millimeter
  • Height: 16 Millimeter
  • Length: 33 Millimeter
  • Angle: 12.5 degree
TXT12163312

  • Metallic spinal interbody fusion cage
Ti 6Al 4V (ELI); Hydroxyapatite
Innovasis, Inc.
TXT12163310
In Commercial Distribution

  • M711TXT121633101 ()
  • M711TXT121633100 ()

  • Width: 12 Millimeter
  • Height: 16 Millimeter
  • Length: 33 Millimeter
  • Angle: 10 degree
TXT12163310

  • Metallic spinal interbody fusion cage
Ti 6Al 4V (ELI); Hydroxyapatite
Innovasis, Inc.
TXT12163305
In Commercial Distribution

  • M711TXT121633051 ()
  • M711TXT121633050 ()

  • Width: 12 Millimeter
  • Height: 16 Millimeter
  • Length: 33 Millimeter
  • Angle: 5 degree
TXT12163305

  • Metallic spinal interbody fusion cage
Ti 6Al 4V (ELI); Hydroxyapatite
Innovasis, Inc.
TXT12153312
In Commercial Distribution

  • M711TXT121533121 ()
  • M711TXT121533120 ()

  • Width: 12 Millimeter
  • Height: 15 Millimeter
  • Length: 33 Millimeter
  • Angle: 12.5 degree
TXT12153312

  • Metallic spinal interbody fusion cage
Ti 6Al 4V (ELI); Hydroxyapatite
Innovasis, Inc.
TXT12153310
In Commercial Distribution

  • M711TXT121533101 ()
  • M711TXT121533100 ()

  • Width: 12 Millimeter
  • Height: 15 Millimeter
  • Length: 33 Millimeter
  • Angle: 10 degree
TXT12153310

  • Metallic spinal interbody fusion cage
Ti 6Al 4V (ELI); Hydroxyapatite
Innovasis, Inc.
TXT12153305
In Commercial Distribution

  • M711TXT121533051 ()
  • M711TXT121533050 ()

  • Width: 12 Millimeter
  • Height: 15 Millimeter
  • Length: 33 Millimeter
  • Angle: 5 degree
TXT12153305

  • Metallic spinal interbody fusion cage
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