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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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No Description
Merit Medical Systems, Inc.
00884450011133
In Commercial Distribution

  • 20884450011137 ()
  • 10884450011130 ()
  • 00884450011133 ()

  • Length-260 cm (102")
  • Configuration-Standard Exchange
  • Tip Shape-3 mm J-Tip
  • Configuration-Standard Exchange; Length-260 cm (102"); Configuration-Standard Exchange; Tip Shape-3 mm J-Tip
  • Tip Shape-3 mm J-Tip; Length-260 cm (102"); Configuration-Standard Exchange; Tip Shape-3 mm J-Tip
IQ35F260J3/B

  • Cardiac/peripheral vascular guidewire, single-use
No Description
Merit Medical Systems, Inc.
00884450004333
In Commercial Distribution

  • 20884450004337 ()
  • 10884450004330 ()
  • 00884450004333 ()

  • Length-260 cm (102")
  • Tip Shape-3 mm J-Tip
  • Configuration-Standard Exchange
  • Configuration-Standard Exchange; Length-260 cm (102"); Tip Shape-3 mm J-Tip; Configuration-Standard Exchange
  • Tip Shape-3 mm J-Tip; Length-260 cm (102"); Tip Shape-3 mm J-Tip; Configuration-Standard Exchange
IQ38F260J3/B

  • Cardiac/peripheral vascular guidewire, single-use
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 medium
In Commercial Distribution

  • 04260102139220 ()
  • 04260102139206 ()
  • 04260102139213 ()
5147216

  • 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 medium
In Commercial Distribution

  • 04260102139190 ()
  • 04260102139176 ()
  • 04260102139183 ()
5147215

  • Orthopaedic cement spacer
The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected total joint, a temporary implant to l) allow for partial weight bearing and 2) provide an approximate natural range of motion. The devices also maintain a patient's soft tissue and joint space, preventing further complications such as muscular contraction. The gentamicin protects the device from bacterial colonization. The COPAL® exchange G Hip and Knee Spacers are placed into the joint to maintain normal joint space and alignment. They provide patient comfort and limited mobility while the infection is being treated. The COPAL® exchange G Hip and Knee Spacers are made with bone cement that are loaded with gentamicin antibiotics. The COPAL® exchange G Hip and Knee Spacers are temporary joint prostheses designed to temporarily replace an infected implant during a total hip or knee arthroplasty and provide the patient with limited mobility and predictable, consistent local antibiotic release.
Heraeus Medical GmbH
knee L
In Commercial Distribution

  • 04260102136991 ()
  • 04260102136977 ()
  • 04260102136984 ()
5034796

  • Orthopaedic cement spacer
The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected total joint, a temporary implant to l) allow for partial weight bearing and 2) provide an approximate natural range of motion. The devices also maintain a patient's soft tissue and joint space, preventing further complications such as muscular contraction. The gentamicin protects the device from bacterial colonization. The COPAL® exchange G Hip and Knee Spacers are placed into the joint to maintain normal joint space and alignment. They provide patient comfort and limited mobility while the infection is being treated. The COPAL® exchange G Hip and Knee Spacers are made with bone cement that are loaded with gentamicin antibiotics. The COPAL® exchange G Hip and Knee Spacers are temporary joint prostheses designed to temporarily replace an infected implant during a total hip or knee arthroplasty and provide the patient with limited mobility and predictable, consistent local antibiotic release.
Heraeus Medical GmbH
knee M
In Commercial Distribution

  • 04260102136960 ()
  • 04260102136946 ()
  • 04260102136953 ()
5034797

  • Orthopaedic cement spacer
The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected total joint, a temporary implant to l) allow for partial weight bearing and 2) provide an approximate natural range of motion. The devices also maintain a patient's soft tissue and joint space, preventing further complications such as muscular contraction. The gentamicin protects the device from bacterial colonization. The COPAL® exchange G Hip and Knee Spacers are placed into the joint to maintain normal joint space and alignment. They provide patient comfort and limited mobility while the infection is being treated. The COPAL® exchange G Hip and Knee Spacers are made with bone cement that are loaded with gentamicin antibiotics. The COPAL® exchange G Hip and Knee Spacers are temporary joint prostheses designed to temporarily replace an infected implant during a total hip or knee arthroplasty and provide the patient with limited mobility and predictable, consistent local antibiotic release.
Heraeus Medical GmbH
knee S
In Commercial Distribution

  • 04260102136939 ()
  • 04260102136915 ()
  • 04260102136922 ()
5034798

  • 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 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
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