COPAL® exchange G 5034796

GUDID 04260102136991

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

Orthopaedic cement spacer

• Primary Device ID: 04260102136991
• NIH Device Record Key: fd91c81b-90f8-4d2d-b7cf-4d6f57a8b3a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COPAL® exchange G
• Version Model Number: knee L
• Catalog Number: 5034796
• Company DUNS: 333623937
• Company Name: Heraeus Medical GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260102136977 [Primary]
GS1	04260102136984 [Package]; Contains: 04260102136977; Package: Carton box [12 Units]; In Commercial Distribution
GS1	04260102136991 [Package]; Contains: 04260102136977; Package: Pallet [144 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191016

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-10
• Device Publish Date: 2019-12-02

On-Brand Devices [COPAL® exchange G]

• 04260102136991: The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
• 04260102136960: The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
• 04260102136939: The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
• 04260102130609: COPAL® exchange G Trials are an accessory device for intra-operative determination of the corre
• 04260102131149: COPAL® exchange G Trials are an accessory device for intra-operative determination of the corre
• 04260102131132: COPAL® exchange G Trials are an accessory device for intra-operative determination of the corre
• 04260102130814: COPAL® exchange G Trials are an accessory device for intra-operative determination of the corre
• 04260102130807: COPAL® exchange G Trials are an accessory device for intra-operative determination of the corre
• 04260102139220: COPAL® exchange G hip spacers provide patients, undergoing a two-stage revision procedure for a
• 04260102139190: COPAL® exchange G hip spacers provide patients, undergoing a two-stage revision procedure for a
• 04260102136885: The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
• 04260102136878: The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
• 04260102136847: The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
• 04260102136816: The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
• 04260102136786: The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
• 04260102136755: The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
• 04260102136724: The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
• 04260102136694: The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev