Aurora Tray

GUDID 09348215067212

SIGNATURE ORTHOPAEDICS PTY LTD

Instrument tray

• Primary Device ID: 09348215067212
• NIH Device Record Key: 72a95e01-dfc9-453e-a93a-d8e28bec4d2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aurora Tray
• Version Model Number: 132-16-1001
• 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	09348215067212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163625

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[09348215067212]

Moist Heat or Steam Sterilization

[09348215067212]

Moist Heat or Steam Sterilization

[09348215067212]

Moist Heat or Steam Sterilization

[09348215067212]

Moist Heat or Steam Sterilization

[09348215067212]

Moist Heat or Steam Sterilization

[09348215067212]

Moist Heat or Steam Sterilization

[09348215067212]

Moist Heat or Steam Sterilization

[09348215067212]

Moist Heat or Steam Sterilization

[09348215067212]

Moist Heat or Steam Sterilization

[09348215067212]

Moist Heat or Steam Sterilization

[09348215067212]

Moist Heat or Steam Sterilization

[09348215067212]

Moist Heat or Steam Sterilization

[09348215067212]

Moist Heat or Steam Sterilization

[09348215067212]

Moist Heat or Steam Sterilization

[09348215067212]

Moist Heat or Steam Sterilization

[09348215067212]

Moist Heat or Steam Sterilization

[09348215067212]

Moist Heat or Steam Sterilization

[09348215067212]

Moist Heat or Steam Sterilization

[09348215067212]

Moist Heat or Steam Sterilization

[09348215067212]

Moist Heat or Steam Sterilization

[09348215067212]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-09
• Device Publish Date: 2020-07-01

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