ALIF Trial Caddy

GUDID 09348215045463

SIGNATURE ORTHOPAEDICS PTY LTD

Instrument tray

• Primary Device ID: 09348215045463
• NIH Device Record Key: fa3158b2-7958-43e1-8123-f8d3fa5c2bf5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALIF Trial Caddy
• Version Model Number: W32-04-0319
• 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	09348215045463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172019

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

[09348215045463]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-06-14
• Device Publish Date: 2019-05-27

On-Brand Devices [ALIF Trial Caddy]

• 09348215045463: W32-04-0319
• 09348215045456: W32-04-0302
• 09348215045449: W32-04-0301
• 09348215045432: W32-04-0300