Everglade Trial Neck, Standard Offset

GUDID 09348215105235

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215105235
• NIH Device Record Key: 12603034-8c05-4a1a-8310-eff4136ae790
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Everglade Trial Neck, Standard Offset
• Version Model Number: 111-45-2020
• 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	09348215105235 [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

[09348215105235]

Moist Heat or Steam Sterilization

[09348215105235]

Moist Heat or Steam Sterilization

[09348215105235]

Moist Heat or Steam Sterilization

[09348215105235]

Moist Heat or Steam Sterilization

[09348215105235]

Moist Heat or Steam Sterilization

[09348215105235]

Moist Heat or Steam Sterilization

[09348215105235]

Moist Heat or Steam Sterilization

[09348215105235]

Moist Heat or Steam Sterilization

[09348215105235]

Moist Heat or Steam Sterilization

[09348215105235]

Moist Heat or Steam Sterilization

[09348215105235]

Moist Heat or Steam Sterilization

[09348215105235]

Moist Heat or Steam Sterilization

[09348215105235]

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, Standard Offset]

• 09348215108960: 111-45-2027
• 09348215105273: 111-45-2024
• 09348215105235: 111-45-2020