COPAL® exchange G 5147215

GUDID 04260102139190

COPAL® exchange G hip spacers provide patients, undergoing a two-stage revision procedure for an infected total joint, a temporary implant to 1) 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. COPAL® exchange G hip 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. COPAL® exchange G hip spacers are made with bone cement containing gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip 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. COPAL® exchange G hip spacers are intended for single-use and are supplied sterile.

Heraeus Medical GmbH

Temporary hip prosthesis

• Primary Device ID: 04260102139190
• NIH Device Record Key: b19545a9-bc63-463f-94a6-9ed487fe2b30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COPAL® exchange G
• Version Model Number: hip S medium
• Catalog Number: 5147215
• 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	04260102139176 [Primary]
GS1	04260102139183 [Package]; Contains: 04260102139176; Package: Carton Box [12 Units]; In Commercial Distribution
GS1	04260102139190 [Package]; Contains: 04260102139176; Package: Pallet [144 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220492

FDA Product Code

• KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

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: 2022-05-23
• Device Publish Date: 2022-05-15

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