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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No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1305
In Commercial Distribution

  • 09348215023881 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1205
In Commercial Distribution

  • 09348215023874 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1105
In Commercial Distribution

  • 09348215023867 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1005
In Commercial Distribution

  • 09348215023850 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0905
In Commercial Distribution

  • 09348215023843 ()


  • Coated femoral stem prosthesis, modular
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 18, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1801
In Commercial Distribution

  • M7161111818010 ()
111-18-1801

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 16, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1601
In Commercial Distribution

  • M7161111816010 ()
111-18-1601

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 15, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1501
In Commercial Distribution

  • M7161111815010 ()
111-18-1501

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 14, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1401
In Commercial Distribution

  • M7161111814010 ()
111-18-1401

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 13, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1301
In Commercial Distribution

  • M7161111813010 ()
111-18-1301

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 12, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1201
In Commercial Distribution

  • M7161111812010 ()
111-18-1201

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 11, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1101
In Commercial Distribution

  • M7161111811010 ()
111-18-1101

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 10, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1001
In Commercial Distribution

  • M7161111810010 ()
111-18-1001

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 9, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-0901
In Commercial Distribution

  • M7161111809010 ()
111-18-0901

  • Press-fit femoral stem prosthesis
Smoke Evac Unit
DEROYAL INDUSTRIES, INC.
88-350D
In Commercial Distribution

  • 00749756252867 ()


  • Surgical plume evacuation system
ExtendEVAC
DEROYAL INDUSTRIES, INC.
88-702NS
In Commercial Distribution

  • 50749756248667 ()
  • 00749756248662 ()


  • Surgical plume evacuation system
Universal Smoke Evac
DEROYAL INDUSTRIES, INC.
88-600NS
In Commercial Distribution

  • 50749756248124 ()
  • 00749756248129 ()


  • Surgical plume evacuation system
ExtendEVAC Electrosurgical Pencil
DEROYAL INDUSTRIES, INC.
88-015722
In Commercial Distribution

  • 50749756248117 ()
  • 00749756248112 ()


  • Surgical plume evacuation system
Adaptor For Valleylab Optimum
DEROYAL INDUSTRIES, INC.
88-000696
In Commercial Distribution

  • 50749756237494 ()
  • 00749756237499 ()
88-000696

  • Surgical plume evacuation system
ExtendEVAC Electrosurgical Pencil
DEROYAL INDUSTRIES, INC.
88-000703
In Commercial Distribution

  • 50749756237487 ()
  • 00749756237482 ()


  • Surgical plume evacuation system
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