World Cup Trial Shell - 54mm

GUDID 09348215066024

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215066024
• NIH Device Record Key: be4ef3c2-76a8-4b8a-86ec-80171f609708
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Cup Trial Shell - 54mm
• Version Model Number: 112-43-0154
• Company DUNS: 751993028
• Company Name: SIGNATURE ORTHOPAEDICS PTY LTD
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	09348215066024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201278

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[09348215066024]

Moist Heat or Steam Sterilization

[09348215066024]

Moist Heat or Steam Sterilization

[09348215066024]

Moist Heat or Steam Sterilization

[09348215066024]

Moist Heat or Steam Sterilization

[09348215066024]

Moist Heat or Steam Sterilization

[09348215066024]

Moist Heat or Steam Sterilization

[09348215066024]

Moist Heat or Steam Sterilization

[09348215066024]

Moist Heat or Steam Sterilization

[09348215066024]

Moist Heat or Steam Sterilization

[09348215066024]

Moist Heat or Steam Sterilization

[09348215066024]

Moist Heat or Steam Sterilization

[09348215066024]

Moist Heat or Steam Sterilization

[09348215066024]

Moist Heat or Steam Sterilization

[09348215066024]

Moist Heat or Steam Sterilization

[09348215066024]

Moist Heat or Steam Sterilization

[09348215066024]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-17
• Device Publish Date: 2021-05-07

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

• 09348215110246 - Rx Knee All Poly Tibia Augment - Full - 4mm: 2024-11-20
• 09348215110253 - Rx Knee All Poly Tibia Augment - Full - 4mm: 2024-11-20
• 09348215110260 - Rx Knee All Poly Tibia Augment - Full - 4mm: 2024-11-20
• 09348215110277 - Rx Knee All Poly Tibia Augment - Full - 4mm: 2024-11-20
• 09348215110284 - Rx Knee All Poly Tibia Augment - Full - 4mm: 2024-11-20
• 09348215110291 - Rx Knee All Poly Tibia Augment - Full - 4mm: 2024-11-20
• 09348215110307 - Rx Knee All Poly Tibia Augment - Full - 4mm: 2024-11-20
• 09348215110314 - Rx Knee All Poly Tibia Augment - Full - 4mm: 2024-11-20