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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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Innomed, Inc. - 00840277109583

Hip Cup Wrench Starter Blade 42mm Exchange
INNOMED, INC.
5205W-42
In Commercial Distribution

  • 00840277109583 ()
5205W-42

  • Orthopaedic inorganic implant inserter/extractor, reusable

JEDMED - M6337065210

CABLE CAMERA W/TOOL F/HEAD EXCHANGE
JEDMED INSTRUMENT COMPANY
70-6521
In Commercial Distribution

  • M6337065210 ()
70-6521

  • Throat microphone

Innomed, Inc. - 00840277124197

Eickmann Offset Cement Removal Chisel 8mm Exchange
INNOMED, INC.
5472-08-E
In Commercial Distribution

  • 00840277124197 ()
5472-08-E

  • Orthopaedic osteotome

COPAL® exchange G - 04260102133044

COPAL® exchange G Trials are an accessory device for intra-operative determination of the correct size of the COPAL® exchange G Spacer. COPAL® exchange G Trials are used for a very short period of time (few minutes) during the first stage of a two-stage exchange septic revision surgery after thorough debridement and are intended for single use. COPAL® exchange G hip and knee Trials resemble the COPAL® exchange G hip and knee Spacers in size, shape and geometry. COPAL® exchange G Trials are easily distin-guishable from COPAL® exchange G Spacers due to their hollow body, their prominent blue color and the stamping “TRIAL - DO NOT IMPLANT”.COPAL® exchange G Trials are available for hip and knee. COPAL® exchange G hip Trials resemble a hemi-endopros-thesis and are available in 8 different sizes. COPAL® exchange G knee Trials consist of a femoral and tibial component and are available in 3 different sizes.COPAL® exchange G Trials do not contain gentamicin.
Heraeus Medical GmbH
Trial Set knee
In Commercial Distribution

  • 04260102130609 ()
  • 04260102133044 ()
  • 04260102131156 ()
5092607

  • Knee revision prosthesis trial

COPAL® exchange G - 04260102130593

COPAL® exchange G Trials are an accessory device for intra-operative determination of the correct size of the COPAL® exchange G Spacer. COPAL® exchange G Trials are used for a very short period of time (few minutes) during the first stage of a two-stage exchange septic revision surgery after thorough debridement and are intended for single use. COPAL® exchange G hip and knee Trials resemble the COPAL® exchange G hip and knee Spacers in size, shape and geometry. COPAL® exchange G Trials are easily distin-guishable from COPAL® exchange G Spacers due to their hollow body, their prominent blue color and the stamping “TRIAL - DO NOT IMPLANT”.COPAL® exchange G Trials are available for hip and knee. COPAL® exchange G hip Trials resemble a hemi-endopros-thesis and are available in 8 different sizes. COPAL® exchange G knee Trials consist of a femoral and tibial component and are available in 3 different sizes.COPAL® exchange G Trials do not contain gentamicin.
Heraeus Medical GmbH
Trial Set hip XL
In Commercial Distribution

  • 04260102131149 ()
  • 04260102130593 ()
  • 04260102131859 ()
5097415

  • Hip revision prosthesis trial

COPAL® exchange G - 04260102130449

COPAL® exchange G Trials are an accessory device for intra-operative determination of the correct size of the COPAL® exchange G Spacer. COPAL® exchange G Trials are used for a very short period of time (few minutes) during the first stage of a two-stage exchange septic revision surgery after thorough debridement and are intended for single use. COPAL® exchange G hip and knee Trials resemble the COPAL® exchange G hip and knee Spacers in size, shape and geometry. COPAL® exchange G Trials are easily distin-guishable from COPAL® exchange G Spacers due to their hollow body, their prominent blue color and the stamping “TRIAL - DO NOT IMPLANT”.COPAL® exchange G Trials are available for hip and knee. COPAL® exchange G hip Trials resemble a hemi-endopros-thesis and are available in 8 different sizes. COPAL® exchange G knee Trials consist of a femoral and tibial component and are available in 3 different sizes.COPAL® exchange G Trials do not contain gentamicin.
Heraeus Medical GmbH
Trial Set hip L
In Commercial Distribution

  • 04260102131132 ()
  • 04260102130449 ()
  • 04260102131842 ()
5097414

  • Hip revision prosthesis trial

COPAL® exchange G - 04260102130432

COPAL® exchange G Trials are an accessory device for intra-operative determination of the correct size of the COPAL® exchange G Spacer. COPAL® exchange G Trials are used for a very short period of time (few minutes) during the first stage of a two-stage exchange septic revision surgery after thorough debridement and are intended for single use. COPAL® exchange G hip and knee Trials resemble the COPAL® exchange G hip and knee Spacers in size, shape and geometry. COPAL® exchange G Trials are easily distin-guishable from COPAL® exchange G Spacers due to their hollow body, their prominent blue color and the stamping “TRIAL - DO NOT IMPLANT”.COPAL® exchange G Trials are available for hip and knee. COPAL® exchange G hip Trials resemble a hemi-endopros-thesis and are available in 8 different sizes. COPAL® exchange G knee Trials consist of a femoral and tibial component and are available in 3 different sizes.COPAL® exchange G Trials do not contain gentamicin.
Heraeus Medical GmbH
Trial Set hip M
In Commercial Distribution

  • 04260102130814 ()
  • 04260102130432 ()
  • 04260102131507 ()
5097413

  • Hip revision prosthesis trial

COPAL® exchange G - 04260102130241

COPAL® exchange G Trials are an accessory device for intra-operative determination of the correct size of the COPAL® exchange G Spacer. COPAL® exchange G Trials are used for a very short period of time (few minutes) during the first stage of a two-stage exchange septic revision surgery after thorough debridement and are intended for single use. COPAL® exchange G hip and knee Trials resemble the COPAL® exchange G hip and knee Spacers in size, shape and geometry. COPAL® exchange G Trials are easily distin-guishable from COPAL® exchange G Spacers due to their hollow body, their prominent blue color and the stamping “TRIAL - DO NOT IMPLANT”.COPAL® exchange G Trials are available for hip and knee. COPAL® exchange G hip Trials resemble a hemi-endopros-thesis and are available in 8 different sizes. COPAL® exchange G knee Trials consist of a femoral and tibial component and are available in 3 different sizes.COPAL® exchange G Trials do not contain gentamicin.
Heraeus Medical GmbH
Trial Set hip S
In Commercial Distribution

  • 04260102130807 ()
  • 04260102130241 ()
  • 04260102131163 ()


  • Hip revision prosthesis trial

OTOVIEW - 00821925027411

REPAIR EXCHANGE OTOVIEW SCOPE 2.4 MM 0 DEGREE
Gyrus ACMI, LLC
REX23-5210
In Commercial Distribution

  • 00821925027411 ()


  • Otoscope, endoscopic

OTOVIEW - 00821925027213

REPAIR EXCHANGE OTOVIEW SCOPE 1.7 MM 30 DEGREES
Gyrus ACMI, LLC
REX23-5201
In Commercial Distribution

  • 00821925027213 ()


  • Otoscope, endoscopic
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