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
111-39-1004
In Commercial Distribution

  • 09348215092757 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-0904
In Commercial Distribution

  • 09348215092740 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1412
In Commercial Distribution

  • 09348215088491 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1313
In Commercial Distribution

  • 09348215088484 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1312
In Commercial Distribution

  • 09348215088477 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1213
In Commercial Distribution

  • 09348215088460 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1212
In Commercial Distribution

  • 09348215088453 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1113
In Commercial Distribution

  • 09348215088446 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1112
In Commercial Distribution

  • 09348215088439 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1013
In Commercial Distribution

  • 09348215088422 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1012
In Commercial Distribution

  • 09348215088415 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-0913
In Commercial Distribution

  • 09348215088408 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-0912
In Commercial Distribution

  • 09348215088392 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-0813
In Commercial Distribution

  • 09348215088385 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-0812
In Commercial Distribution

  • 09348215088378 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0805
In Commercial Distribution

  • 09348215083533 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1813
In Commercial Distribution

  • 09348215088569 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1812
In Commercial Distribution

  • 09348215088552 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1613
In Commercial Distribution

  • 09348215088545 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1612
In Commercial Distribution

  • 09348215088538 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1513
In Commercial Distribution

  • 09348215088521 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1512
In Commercial Distribution

  • 09348215088514 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1413
In Commercial Distribution

  • 09348215088507 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-027
In Commercial Distribution

  • 09348215081423 ()


  • Surgical implant template, reusable
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11668590
In Commercial Distribution

  • 04056869996295 ()


  • General-purpose ultrasound imaging system
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
Includes TX Nozzle, preliminary filter, 18" hose section assembly, connects to Hose, Intended for long procedures of up to 1 hour duration
ACUDERM, INC.
LTXPACK
In Commercial Distribution

  • 10814105020507 ()


  • Surgical plume evacuation system
Includes TX Nozzle, preliminary filter, 8" hose section assembly, connects to Hose, Intended for short procedures of up to 15 minutes duration
ACUDERM, INC.
TXPACK
In Commercial Distribution

  • 10814105020491 ()


  • Surgical plume evacuation system
Top of the line surgical smoke evacuator. Specifically designed for use with erbium smoke. Also suitable for use with CO2, hair removal, and other laser or electrosurgical units in open procedures or with reducer for handpiece or 220vac motor
ACUDERM, INC.
EVAC II-2
In Commercial Distribution

  • 10814105020460 ()


  • Surgical plume evacuation system
Top of the line surgical smoke evacuator. Specifically designed for use with erbium smoke. Also suitable for use with CO2, hair removal, and other laser or electrosurgical units in open procedures or with reducer for handpiece or laparoscopic use. 110vac motor
ACUDERM, INC.
EVAC II-1
In Commercial Distribution

  • 10814105020453 ()


  • Surgical plume evacuation system
All purpose surgical smoke evacuator. Suitable for use with CO2, erbium, hair removal, and other laser or electrosurgical units in open procedures. 220vac motor
ACUDERM, INC.
EVAC IE-2
In Commercial Distribution

  • 10814105020446 ()


  • Surgical plume evacuation system
All purpose surgical smoke evacuator. Suitable for use with CO2, erbium, hair removal, and other laser or electrosurgical units in open procedures. 110vac motor
ACUDERM, INC.
EVAC IE-1
In Commercial Distribution

  • 10814105020439 ()


  • Surgical plume evacuation system
Wall Mount starter package includes Acu-Evac II, Wall mount bracket, M-1 main filter, Hose and 5 TX Nozzles
ACUDERM, INC.
STARTER-IIW
In Commercial Distribution

  • 10814105020422 ()


  • Surgical plume evacuation system
Wall Mount starter package includes Acu-Evac IE, Wall mount bracket, M-1 main filter, Hose and 5 TX Nozzles
ACUDERM, INC.
STARTER-IEW
In Commercial Distribution

  • 10814105020415 ()


  • Surgical plume evacuation system
Cart mount starter package includes Acu-Evac II unit, Cart, Boom Arm, Foot Switch, M-1 Main Filter, Hose and 5 TX Nozzles.
ACUDERM, INC.
STARTER-II
In Commercial Distribution

  • 10814105020408 ()


  • Surgical plume evacuation system
Cart mount starter package includes Acu-Evac IE unit, Cart, Boom Arm, Foot Switch, M-1 Main Filter, Hose and 5 TX Nozzles.
ACUDERM, INC.
STARTER-IE
In Commercial Distribution

  • 10814105020392 ()


  • Surgical plume evacuation system
SafeAir Compact Smoke Evacuator
STRYKER CORPORATION
0703-045-000
In Commercial Distribution

  • 07613327466249 ()
0703-045-000

  • Surgical plume evacuation system
7 m Extension Tubing
STRYKER CORPORATION
0703-045-003
In Commercial Distribution

  • 07613327504125 ()
0703-045-003

  • Surgical plume evacuation system
Grounding Cable
STRYKER CORPORATION
0703-045-002
In Commercial Distribution

  • 07613327504118 ()
0703-045-002

  • Surgical plume evacuation system
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
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