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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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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 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 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 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
The MediPines Gas Exchange Monitor (GEM) is a non-invasive, multi-parameter respiratory monitoring device that provides spot-check respiratory gas measurements of oxygen (PO2, ETO2) and carbon dioxide (PCO2, ETCO2) from breathing, respiration rate (RR), functional saturation of arterial hemoglobin (SpO2), pulse rate (PR), and a range of other calculated indices.
MEDIPINES CORPORATION
AGM100
In Commercial Distribution

  • 00860001261509 ()
AGM100

  • Multiple vital physiological parameter monitoring system, clinical
  • Respiration monitor
  • Patient monitoring system module, multiple-gas
No Description
Respironics Novametrix, LLC
00
In Commercial Distribution

  • 00884838033863 ()
U7167-37

  • Patient monitoring system module, carbon dioxide
No Description
Merit Medical Systems, Inc.
00884450239711
In Commercial Distribution

  • 10884450239718 ()
  • 00884450239711 ()
  • 20884450239715 ()

  • Configuration-Amplatz Exchange; Tip Shape-Straight (6.0 cm) Tip; Configuration-Amplatz Exchange; Length-260 cm (102")
  • Length-260 cm (102"); Tip Shape-Straight (6.0 cm) Tip; Configuration-Amplatz Exchange; Length-260 cm (102")
  • Tip Shape-Straight (6.0 cm) Tip
  • Configuration-Amplatz Exchange
  • Length-260 cm (102")
IQA520

  • Cardiac/peripheral vascular guidewire, single-use
CROSSER® CTO Recanalization Catheter 14S, Rapid Exchange, 106cm
Bard Peripheral Vascular, Inc.
CRUS106
In Commercial Distribution

  • 10801741125635 ()

  • Length: 106 Centimeter
CRUS106

  • Mechanical atherectomy system catheter, coronary/peripheral
CROSSER® CTO Recanalization Catheter 14S, Rapid Exchange, 146cm
Bard Peripheral Vascular, Inc.
CRU14SA
In Commercial Distribution

  • 10801741125567 ()

  • Length: 146 Centimeter
CRU14SA

  • Mechanical atherectomy system catheter, coronary/peripheral
ENCOURAGE PTCA BALLOON CATHETER 4.0mm X 12mm RAPID EXCHANGE
MEDAS INC
M92140012
In Commercial Distribution

  • 00819667020630 ()
M92140012

  • Coronary angioplasty balloon catheter, basic
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