Genius Tibial Trial Monobloc PS - 16mm

GUDID 09348215072438

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215072438
• NIH Device Record Key: aa221047-4e61-4787-bc3c-2581320a8c4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genius Tibial Trial Monobloc PS - 16mm
• Version Model Number: 122-10-0916
• 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	09348215072438 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170613

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

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

[09348215072438]

Moist Heat or Steam Sterilization

[09348215072438]

Moist Heat or Steam Sterilization

[09348215072438]

Moist Heat or Steam Sterilization

[09348215072438]

Moist Heat or Steam Sterilization

[09348215072438]

Moist Heat or Steam Sterilization

[09348215072438]

Moist Heat or Steam Sterilization

[09348215072438]

Moist Heat or Steam Sterilization

[09348215072438]

Moist Heat or Steam Sterilization

[09348215072438]

Moist Heat or Steam Sterilization

[09348215072438]

Moist Heat or Steam Sterilization

[09348215072438]

Moist Heat or Steam Sterilization

[09348215072438]

Moist Heat or Steam Sterilization

[09348215072438]

Moist Heat or Steam Sterilization

[09348215072438]

Moist Heat or Steam Sterilization

[09348215072438]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-28
• Device Publish Date: 2020-08-20

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