COPAL® knee moulds 5159870

GUDID 04260102139299

COPAL® knee moulds are sterile single-use moulds used for the preparation of spacers that are intended as temporary knee replacements as part of two-stage septic joint prosthesis revision. COPAL® knee moulds comprise a tibial component and a femoral component, which together form a bearing and move against one another. They can be used in both the right and the left knee joint. The spacer function provides that after removal of the prosthesis the existing joint space is retained and contraction of the musculature and the surrounding tissues is prevented. COPAL® knee moulds are intended for single use and must not be re-used or resterilised.

Heraeus Medical GmbH

Orthopaedic cement spacer mould

• Primary Device ID: 04260102139299
• NIH Device Record Key: ccc3db1b-f4ab-4103-919f-f955074a5f65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COPAL® knee moulds
• Version Model Number: L
• Catalog Number: 5159870
• 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: 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	04260102139299 [Primary]
GS1	04260102139305 [Package]; Package: Carton [1 Units]; In Commercial Distribution
GS1	04260102139312 [Package]; Contains: 04260102139305; Package: Palette [64 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222570

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: 2023-05-01
• Device Publish Date: 2023-04-21

On-Brand Devices [COPAL® knee moulds]

• 04260102139299: COPAL® knee moulds are sterile single-use moulds used for the preparation of spacers that are i
• 04260102139275: COPAL® knee moulds are sterile single-use moulds used for the preparation of spacers that are i
• 04260102139244: COPAL® knee moulds are sterile single-use moulds used for the preparation of spacers that are i