Origin NS Stem Trial

GUDID 09348215087371

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215087371
• NIH Device Record Key: f8f2a715-85df-4770-90c1-66ce0cac38fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Origin NS Stem Trial
• Version Model Number: 111-23-7020
• 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: 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	09348215087371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181340

FDA Product Code

• JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Sterilization

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

[09348215087371]

Moist Heat or Steam Sterilization

[09348215087371]

Moist Heat or Steam Sterilization

[09348215087371]

Moist Heat or Steam Sterilization

[09348215087371]

Moist Heat or Steam Sterilization

[09348215087371]

Moist Heat or Steam Sterilization

[09348215087371]

Moist Heat or Steam Sterilization

[09348215087371]

Moist Heat or Steam Sterilization

[09348215087371]

Moist Heat or Steam Sterilization

[09348215087371]

Moist Heat or Steam Sterilization

[09348215087371]

Moist Heat or Steam Sterilization

[09348215087371]

Moist Heat or Steam Sterilization

[09348215087371]

Moist Heat or Steam Sterilization

[09348215087371]

Moist Heat or Steam Sterilization

[09348215087371]

Moist Heat or Steam Sterilization

[09348215087371]

Moist Heat or Steam Sterilization

[09348215087371]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-11
• Device Publish Date: 2021-10-01

On-Brand Devices [Origin NS Stem Trial]

• 09348215087401: 111-23-7050
• 09348215087395: 111-23-7040
• 09348215087388: 111-23-7030
• 09348215087371: 111-23-7020
• 09348215087364: 111-23-7010
• 09348215087357: 111-23-7000