COPAL® exchange G

GUDID 04260102130807

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

• Primary Device ID: 04260102130807
• NIH Device Record Key: bac26d98-e4d1-4c5f-bc5a-3bc3d16286c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COPAL® exchange G
• Version Model Number: Trial Set hip S
• 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	04260102130241 [Primary]
GS1	04260102130807 [Package]; Contains: 04260102130241; Package: Carton [15 Units]; In Commercial Distribution
GS1	04260102131163 [Package]; Contains: 04260102130241; 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