Asymmetric Keel Punch Guide Size 1

GUDID 09348215118037

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 09348215118037
• NIH Device Record Key: 261d7b99-af6f-4b18-b8ac-590752af20e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Asymmetric Keel Punch Guide Size 1
• Version Model Number: 122-18-1355
• Company DUNS: 751993028
• Company Name: SIGNATURE ORTHOPAEDICS PTY LTD
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	09348215118037 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[09348215118037]

Moist Heat or Steam Sterilization

[09348215118037]

Moist Heat or Steam Sterilization

[09348215118037]

Moist Heat or Steam Sterilization

[09348215118037]

Moist Heat or Steam Sterilization

[09348215118037]

Moist Heat or Steam Sterilization

[09348215118037]

Moist Heat or Steam Sterilization

[09348215118037]

Moist Heat or Steam Sterilization

[09348215118037]

Moist Heat or Steam Sterilization

[09348215118037]

Moist Heat or Steam Sterilization

[09348215118037]

Moist Heat or Steam Sterilization

[09348215118037]

Moist Heat or Steam Sterilization

[09348215118037]

Moist Heat or Steam Sterilization

[09348215118037]

Moist Heat or Steam Sterilization

[09348215118037]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-03
• Device Publish Date: 2025-08-26

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

• 09348215148898 - Rx Knee Femoral Box Cut Guide Size 1 - 2: 2025-09-04
• 09348215148904 - Rx Knee Femoral Box Cut Guide Size 3 - 4: 2025-09-04
• 09348215148911 - Rx Knee Femoral Box Cut Guide Size 5- 6: 2025-09-04
• 09348215148928 - Rx Knee Femoral Box Cut Guide Size 7 - 8: 2025-09-04
• 09348215148935 - Rx Knee Femoral Box Cut Guide Size 9 - 9: 2025-09-04
• 09348215117658 - Patella Sizer: 2025-09-03
• 09348215117665 - Ligament Balancing Block Size 10-12: 2025-09-03
• 09348215117672 - Ligament Balancing Block Size 14-16: 2025-09-03