Everglade Trial Neck, High Offset

GUDID 09348215105280

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215105280
• NIH Device Record Key: 6fa7ec1b-3f96-4b6d-9767-32062d4ed10c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Everglade Trial Neck, High Offset
• Version Model Number: 111-45-2025
• 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	09348215105280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211505

FDA Product Code

• HWT: Template

Sterilization

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

[09348215105280]

Moist Heat or Steam Sterilization

[09348215105280]

Moist Heat or Steam Sterilization

[09348215105280]

Moist Heat or Steam Sterilization

[09348215105280]

Moist Heat or Steam Sterilization

[09348215105280]

Moist Heat or Steam Sterilization

[09348215105280]

Moist Heat or Steam Sterilization

[09348215105280]

Moist Heat or Steam Sterilization

[09348215105280]

Moist Heat or Steam Sterilization

[09348215105280]

Moist Heat or Steam Sterilization

[09348215105280]

Moist Heat or Steam Sterilization

[09348215105280]

Moist Heat or Steam Sterilization

[09348215105280]

Moist Heat or Steam Sterilization

[09348215105280]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-29
• Device Publish Date: 2022-08-19

On-Brand Devices [Everglade Trial Neck, High Offset]

• 09348215108977: 111-45-2028
• 09348215105280: 111-45-2025
• 09348215105242: 111-45-2021