All Poly Tibia Trial Shim

GUDID 09348215063849

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215063849
• NIH Device Record Key: 1335fb0b-c454-43d6-97b4-6e2b54db245c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: All Poly Tibia Trial Shim
• Version Model Number: 122-18-0326
• 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	09348215063849 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170613

FDA Product Code

• HWT: Template

Sterilization

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

[09348215063849]

Moist Heat or Steam Sterilization

[09348215063849]

Moist Heat or Steam Sterilization

[09348215063849]

Moist Heat or Steam Sterilization

[09348215063849]

Moist Heat or Steam Sterilization

[09348215063849]

Moist Heat or Steam Sterilization

[09348215063849]

Moist Heat or Steam Sterilization

[09348215063849]

Moist Heat or Steam Sterilization

[09348215063849]

Moist Heat or Steam Sterilization

[09348215063849]

Moist Heat or Steam Sterilization

[09348215063849]

Moist Heat or Steam Sterilization

[09348215063849]

Moist Heat or Steam Sterilization

[09348215063849]

Moist Heat or Steam Sterilization

[09348215063849]

Moist Heat or Steam Sterilization

[09348215063849]

Moist Heat or Steam Sterilization

[09348215063849]

Moist Heat or Steam Sterilization

[09348215063849]

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

On-Brand Devices [All Poly Tibia Trial Shim]

• 09348215063849: 122-18-0326
• 09348215063832: 122-18-0325
• 09348215063825: 122-18-0324