Heraeus Medical GmbH

Address:PHILIPP-REIS-STRASSE 8/13,WEHRHEIM Hesse,DE

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- Catalog Number : 5081290

Device Description : The PALACOS® MV+G pro system consists of a mixing and application system prefill The PALACOS® MV+G pro system consists of a mixing and application system prefilled with PALACOS® polymer powder and monomer liquid. PALACOS® MV+G pro is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

Device Class :

Duns Number: 333623937

Premarket Exempt : No

Product Code : MBB, KIH, JDZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 5081291

Device Description : The PALACOS® MV+G pro system consists of a mixing and application system prefill The PALACOS® MV+G pro system consists of a mixing and application system prefilled with PALACOS® polymer powder and monomer liquid. PALACOS® MV+G pro is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

Device Class :

Duns Number: 333623937

Premarket Exempt : No

Product Code : MBB, KIH, JDZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 5087347

Device Description : PALACOS® MV is intended for use in arthroplastic procedures of the hip, knee, an PALACOS® MV is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone. PALACOS® MV contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field PALACOS® MV has been coloured with chlorophyll (E141).The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes.

Device Class :

Duns Number: 333623937

Premarket Exempt : No

Product Code : LOD

Prescription Use : Yes

Device Count : 1

- Catalog Number : 5034792

Device Description : The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing 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.

Device Class :

Duns Number: 333623937

Premarket Exempt : No

Product Code : KWL, KWY

Prescription Use : Yes

Device Count : 1

- Catalog Number : 5034790

Device Description : The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing 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

Device Class :

Duns Number: 333623937

Premarket Exempt : No

Product Code : KWL, KWY

Prescription Use : Yes

Device Count : 1

- Catalog Number : 5034785

Device Description : The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing 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.

Device Class :

Duns Number: 333623937

Premarket Exempt : No

Product Code : KWL, KWY

Prescription Use : Yes

Device Count : 1

- Catalog Number : 5034794

Device Description : The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing 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.

Device Class :

Duns Number: 333623937

Premarket Exempt : No

Product Code : KWL, KWY

Prescription Use : Yes

Device Count : 1

- Catalog Number : 5034793

Device Description : The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing 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.

Device Class :

Duns Number: 333623937

Premarket Exempt : No

Product Code : KWL, KWY

Prescription Use : Yes

Device Count : 1

- Catalog Number : 5034791

Device Description : The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing 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.

Device Class :

Duns Number: 333623937

Premarket Exempt : No

Product Code : KWL, KWY

Prescription Use : Yes

Device Count : 1

- Catalog Number : 5034788

Device Description : The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing 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.

Device Class :

Duns Number: 333623937

Premarket Exempt : No

Product Code : KWL, KWY

Prescription Use : Yes

Device Count : 1