All Poly Monotrial UC

GUDID 09348215081331

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215081331
• NIH Device Record Key: fe401b53-6fe5-47dc-acdd-b59d889f1b9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: All Poly Monotrial UC
• Version Model Number: 122-18-0476
• 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	09348215081331 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181530

FDA Product Code

• HWT: Template

Sterilization

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

[09348215081331]

Moist Heat or Steam Sterilization

[09348215081331]

Moist Heat or Steam Sterilization

[09348215081331]

Moist Heat or Steam Sterilization

[09348215081331]

Moist Heat or Steam Sterilization

[09348215081331]

Moist Heat or Steam Sterilization

[09348215081331]

Moist Heat or Steam Sterilization

[09348215081331]

Moist Heat or Steam Sterilization

[09348215081331]

Moist Heat or Steam Sterilization

[09348215081331]

Moist Heat or Steam Sterilization

[09348215081331]

Moist Heat or Steam Sterilization

[09348215081331]

Moist Heat or Steam Sterilization

[09348215081331]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-15
• Device Publish Date: 2021-03-05

On-Brand Devices [All Poly Monotrial UC]

• 09348215081362: 122-18-0479
• 09348215081355: 122-18-0478
• 09348215081348: 122-18-0477
• 09348215081331: 122-18-0476
• 09348215081324: 122-18-0475
• 09348215081317: 122-18-0474
• 09348215081300: 122-18-0473
• 09348215081294: 122-18-0472
• 09348215081287: 122-18-0471