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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 hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile. COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
Heraeus Medical GmbH
hip XL short
In Commercial Distribution

  • 04260102136885 ()
  • 04260102136908 ()
  • 04260102136892 ()
5034795

  • Orthopaedic cement spacer
COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile. COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
Heraeus Medical GmbH
hip L short
In Commercial Distribution

  • 04260102136878 ()
  • 04260102136854 ()
  • 04260102136861 ()
5034788

  • Orthopaedic cement spacer
COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile. COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
Heraeus Medical GmbH
hip M short
In Commercial Distribution

  • 04260102136847 ()
  • 04260102136823 ()
  • 04260102136830 ()
5034791

  • Orthopaedic cement spacer
COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile. COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
Heraeus Medical GmbH
hip S short
In Commercial Distribution

  • 04260102136816 ()
  • 04260102136793 ()
  • 04260102136809 ()
5034793

  • Orthopaedic cement spacer
COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile. COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
Heraeus Medical GmbH
hip XL long
In Commercial Distribution

  • 04260102136786 ()
  • 04260102136762 ()
  • 04260102136779 ()
5034794

  • Orthopaedic cement spacer
COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile. COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
Heraeus Medical GmbH
hip L long
In Commercial Distribution

  • 04260102136755 ()
  • 04260102136731 ()
  • 04260102136748 ()
5034785

  • Orthopaedic cement spacer
COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile. COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
Heraeus Medical GmbH
hip M long
In Commercial Distribution

  • 04260102136724 ()
  • 04260102136700 ()
  • 04260102136717 ()
5034790

  • Orthopaedic cement spacer
COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile. COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
Heraeus Medical GmbH
hip S long
In Commercial Distribution

  • 04260102136694 ()
  • 04260102136670 ()
  • 04260102136687 ()
5034792

  • Orthopaedic cement spacer
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 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
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
Ion exchange chromatography analyzer sold with lithium accelerated column.
BIOCHROM LIMITED
80-6000-52
In Commercial Distribution

  • 05056336800215 ()


  • Amino acid analyser IVD
Scanner S600 V3 ARTI 230 V without Scansoftware "exchange"
ZIRKONZAHN SRL
ERAB4031
In Commercial Distribution

  • D800ERAB4031 ()


  • Dental milling system, CAD/CAM, laboratory
5.5mm 20cm Threaded Shaft for Exchange, 20cm Working Length
Surgical Direct, Inc.
SD1014209
In Commercial Distribution

  • B382SD10142090 ()

  • Length: 20 Centimeter
  • Outer Diameter: 5.5 Millimeter
SD1014209

  • Endoscope sheath, reusable
REPAIR EXCHANGE AUTOCLAVABLE SCOPE 2.7 MM 30 DEGREES WIDE
Gyrus ACMI, LLC
REX70230914
In Commercial Distribution

  • 00821925027169 ()


  • Rigid optical sinoscope
REPAIR EXCHANGE AUTOCLAVABLE SCOPE 2.7 MM 0 DEGREES WIDE
Gyrus ACMI, LLC
REX70230913
In Commercial Distribution

  • 00821925027152 ()


  • Rigid optical sinoscope
REPAIR EXCHANGE AUTOCLAVABLE SCOPE 4 MM 70 DEGREES WIDE
Gyrus ACMI, LLC
REX70230912
In Commercial Distribution

  • 00821925027145 ()


  • Rigid optical sinoscope
REPAIR EXCHANGE AUTOCLAVABLE SCOPE 4 MM 30 DEGREES WIDE
Gyrus ACMI, LLC
REX70230911
In Commercial Distribution

  • 00821925027121 ()


  • Rigid optical sinoscope
ENCOURAGE PTCA BALLOON CATHETER 4.0mm X 12mm RAPID EXCHANGE
MEDAS INC
M92140012
In Commercial Distribution

  • 00819667020630 ()
M92140012

  • Coronary angioplasty balloon catheter, basic
ENCOURAGE PTCA BALLOON CATHETER 3.0mm X 16mm RAPID EXCHANGE
MEDAS INC
M92130016
In Commercial Distribution

  • 00819667020616 ()
M92130016

  • Coronary angioplasty balloon catheter, basic
ENCOURAGE PTCA BALLOON CATHETER 2.75mm X 16mm RAPID EXCHANGE
MEDAS INC
M92127016
In Commercial Distribution

  • 00819667020586 ()
M92127016

  • Coronary angioplasty balloon catheter, basic
ENCOURAGE PTCA BALLOON CATHETER 2.5mm X 20mm RAPID EXCHANGE
MEDAS INC
M92125020
In Commercial Distribution

  • 00819667020579 ()
M92125020

  • Coronary angioplasty balloon catheter, basic
ENCOURAGE PTCA BALLOON CATHETER 2.0mm X 26mm RAPID EXCHANGE
MEDAS INC
M92120026
In Commercial Distribution

  • 00819667020562 ()
M92120026

  • Coronary angioplasty balloon catheter, basic
ENCOURAGE PTCA BALLOON CATHETER 2.0mm X 20mm RAPID EXCHANGE
MEDAS INC
M92120020
In Commercial Distribution

  • 00819667020555 ()
M92120020

  • Coronary angioplasty balloon catheter, basic
ENCOURAGE PTCA BALLOON CATHETER 2.0mm X 14mm RAPID EXCHANGE
MEDAS INC
M92120014
In Commercial Distribution

  • 00819667020524 ()
M92120014

  • Coronary angioplasty balloon catheter, basic
ENCOURAGE PTCA BALLOON CATHETER 1.75mm X 20mm RAPID EXCHANGE
MEDAS INC
M92117020
In Commercial Distribution

  • 00819667020517 ()
M92117020

  • Coronary angioplasty balloon catheter, basic
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