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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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AlliedSil™ Sheeting - M72423701201

Silicone Sheeting Reinforced
IMPLANTECH ASSOCIATES, INC.
Size: 50.8mm x 76.2mm x 0.508mm
In Commercial Distribution

  • M72423701202 ()
  • M72423701201 ()
23-701-20

  • Silicone-sheet tissue reconstructive material, non-sterile

AlliedSil™ Sheeting - M72423701071

Silicone Sheeting Reinforced
IMPLANTECH ASSOCIATES, INC.
Size: 50.8mm x 76.2mm x 0.178mm
In Commercial Distribution

  • M72423701072 ()
  • M72423701071 ()
23-701-07

  • Silicone-sheet tissue reconstructive material, non-sterile

AlliedSil™ Sheeting - M72423700401

Silicone Sheeting Non-Reinforced
IMPLANTECH ASSOCIATES, INC.
Size: 50.8mm x 76.2mm x 1.016mm
In Commercial Distribution

  • M72423700402 ()
  • M72423700401 ()
23-700-40

  • Silicone-sheet tissue reconstructive material, non-sterile

RICHPLAT ORTHO PRP SYSTEM - M713FPRP200

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

TxTiHA® - M711TXT121633120

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

TxTiHA® - M711TXT121633100

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

TxTiHA® - M711TXT121633050

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

TxTiHA® - M711TXT121533120

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

TxTiHA® - M711TXT121533100

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

TxTiHA® - M711TXT121533050

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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