COPAL® exchange G 5097413

GUDID 04260102130814

COPAL® exchange G Trials are an accessory device for intra-operative determination of the correct size of the COPAL® exchange G Spacer. COPAL® exchange G Trials are used for a very short period of time (few minutes) during the first stage of a two-stage exchange septic revision surgery after thorough debridement and are intended for single use. COPAL® exchange G hip and knee Trials resemble the COPAL® exchange G hip and knee Spacers in size, shape and geometry. COPAL® exchange G Trials are easily distin-guishable from COPAL® exchange G Spacers due to their hollow body, their prominent blue color and the stamping “TRIAL - DO NOT IMPLANT”.COPAL® exchange G Trials are available for hip and knee. COPAL® exchange G hip Trials resemble a hemi-endopros-thesis and are available in 8 different sizes. COPAL® exchange G knee Trials consist of a femoral and tibial component and are available in 3 different sizes.COPAL® exchange G Trials do not contain gentamicin.

Heraeus Medical GmbH

Hip revision prosthesis trial Hip revision prosthesis trial Hip revision prosthesis trial Hip revision prosthesis trial Hip revision prosthesis trial Hip revision prosthesis trial Hip revision prosthesis trial Hip revision prosthesis trial Hip revision prosthesis trial Hip revision prosthesis trial Hip revision prosthesis trial Hip revision prosthesis trial Hip revision prosthesis trial Hip revision prosthesis trial

• Primary Device ID: 04260102130814
• NIH Device Record Key: 87ac7dd6-22ad-4fda-8d0b-5f6e7fd6dd38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COPAL® exchange G
• Version Model Number: Trial Set hip M
• Catalog Number: 5097413
• 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	04260102130432 [Primary]
GS1	04260102130814 [Package]; Contains: 04260102130432; Package: Carton [15 Units]; In Commercial Distribution
GS1	04260102131507 [Package]; Contains: 04260102130432; Package: Pallet [210 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: 2020-07-15
• Device Publish Date: 2020-07-07

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