TriVerse Tibial Insert Trial

GUDID 09348215113865

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215113865
• NIH Device Record Key: d4a7a06d-8b9c-4173-a29d-46671b20d293
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriVerse Tibial Insert Trial
• Version Model Number: 02-039-47-5915
• 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	09348215113865 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222380

FDA Product Code

• HWT: Template

Sterilization

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

[09348215113865]

Moist Heat or Steam Sterilization

[09348215113865]

Moist Heat or Steam Sterilization

[09348215113865]

Moist Heat or Steam Sterilization

[09348215113865]

Moist Heat or Steam Sterilization

[09348215113865]

Moist Heat or Steam Sterilization

[09348215113865]

Moist Heat or Steam Sterilization

[09348215113865]

Moist Heat or Steam Sterilization

[09348215113865]

Moist Heat or Steam Sterilization

[09348215113865]

Moist Heat or Steam Sterilization

[09348215113865]

Moist Heat or Steam Sterilization

[09348215113865]

Moist Heat or Steam Sterilization

[09348215113865]

Moist Heat or Steam Sterilization

[09348215113865]

Moist Heat or Steam Sterilization

[09348215113865]

Moist Heat or Steam Sterilization

[09348215113865]

Moist Heat or Steam Sterilization

[09348215113865]

Moist Heat or Steam Sterilization

[09348215113865]

Moist Heat or Steam Sterilization

[09348215113865]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-28
• Device Publish Date: 2023-02-20

On-Brand Devices [TriVerse Tibial Insert Trial]

• 09348215113988: 02-039-47-8715
• 09348215113971: 02-039-47-8713
• 09348215113964: 02-039-47-8711
• 09348215113957: 02-039-47-7915
• 09348215113940: 02-039-47-7913
• 09348215113933: 02-039-47-7911
• 09348215113926: 02-039-47-7115
• 09348215113919: 02-039-47-7113
• 09348215113902: 02-039-47-7111
• 09348215113896: 02-039-47-6315
• 09348215113889: 02-039-47-6313
• 09348215113872: 02-039-47-6311
• 09348215113865: 02-039-47-5915
• 09348215113858: 02-039-47-5913
• 09348215113841: 02-039-47-5911
• 09348215110017: 02-039-47-8718
• 09348215110000: 02-039-47-8716
• 09348215109998: 02-039-47-8714
• 09348215109981: 02-039-47-8712
• 09348215109974: 02-039-47-8710
• 09348215109967: 02-039-47-7918
• 09348215109950: 02-039-47-7916
• 09348215109943: 02-039-47-7914
• 09348215109936: 02-039-47-7912
• 09348215109929: 02-039-47-7910
• 09348215109912: 02-039-47-7118
• 09348215109905: 02-039-47-7116
• 09348215109899: 02-039-47-7114
• 09348215109882: 02-039-47-7112
• 09348215109875: 02-039-47-7110
• 09348215109868: 02-039-47-6318
• 09348215109851: 02-039-47-6316
• 09348215109844: 02-039-47-6314
• 09348215109837: 02-039-47-6312
• 09348215109820: 02-039-47-6310
• 09348215109660: 02-039-47-5918
• 09348215109653: 02-039-47-5916
• 09348215109646: 02-039-47-5914
• 09348215109639: 02-039-47-5912
• 09348215109622: 02-039-47-5910
• 09348215100087: 02-039-47-8724
• 09348215100070: 02-039-47-8722
• 09348215100063: 02-039-47-8720
• 09348215100056: 02-039-47-7924
• 09348215100049: 02-039-47-7922
• 09348215100032: 02-039-47-7920
• 09348215100025: 02-039-47-7124
• 09348215100018: 02-039-47-7122
• 09348215100001: 02-039-47-7120
• 09348215099992: 02-039-47-6324