All Poly Monotrial

GUDID 09348215063818

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215063818
• NIH Device Record Key: 50078113-85d0-46d0-b4db-26fdb0a3fb03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: All Poly Monotrial
• Version Model Number: 122-18-0350
• 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	09348215063818 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170613
• Premarket Notification: K181530

FDA Product Code

• HWT: Template

Sterilization

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

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

[09348215063818]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-11
• Device Publish Date: 2020-06-03

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• 09348215027193 - Freedom Pedicle Screw System: 2024-11-07
• 09348215027209 - Freedom Pedicle Screw System: 2024-11-07
• 09348215027216 - Freedom Pedicle Screw System: 2024-11-07
• 09348215027223 - Freedom Pedicle Screw System: 2024-11-07
• 09348215027230 - Freedom Pedicle Screw System: 2024-11-07
• 09348215027247 - Freedom Pedicle Screw System: 2024-11-07