COPAL® knee mould Trial M US 5165923

GUDID 04260102139336

COPAL® knee mould Trials are an accessory device for intraoperative determination of the correct size of spacer made from COPAL® knee moulds (Size S: 5159868, Size M: 5159869, Size L: 5159870). COPAL® knee mould Trials are used for a very short period of time (few minutes) during the first stage of a two-stage exchange revision procedure due to a septic process after thorough debridement and are intended for single use. COPAL® knee mould Trials resemble the spacer made from COPAL® knee moulds in size, shape, and geometry. COPAL® knee mould Trials are easily distinguishable from COPAL® knee mould spacers due to their prominent blue color and the stamping “Do not implant”.

Heraeus Medical GmbH

Knee revision prosthesis trial

• Primary Device ID: 04260102139336
• NIH Device Record Key: a27a8643-b40f-4c93-8360-fd078370971c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COPAL® knee mould Trial M US
• Version Model Number: M
• Catalog Number: 5165923
• Company DUNS: 333623937
• Company Name: Heraeus Medical GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• 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	04260102139329 [Primary]
GS1	04260102139336 [Package]; Contains: 04260102139329; Package: Carton [15 Units]; In Commercial Distribution
GS1	04260102139343 [Package]; Contains: 04260102139329; Package: Pallet [270 Units]; In Commercial Distribution

FDA Product Code

• HWT: Template

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: 2023-07-03
• Device Publish Date: 2023-06-25

Devices Manufactured by Heraeus Medical GmbH

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• 04260102136694 - COPAL® exchange G: 2024-02-16 The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected
• 04260102136724 - COPAL® exchange G: 2024-02-16 The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected
• 04260102136755 - COPAL® exchange G: 2024-02-16 The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected
• 04260102136786 - COPAL® exchange G: 2024-02-16 The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected
• 04260102136816 - COPAL® exchange G: 2024-02-16 The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected
• 04260102136847 - COPAL® exchange G: 2024-02-16 The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected
• 04260102136878 - COPAL® exchange G: 2024-02-16 The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected