Evolve Broach

GUDID 09348215002848

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic broach

• Primary Device ID: 09348215002848
• NIH Device Record Key: e54bdab2-54b4-4fe8-a9e2-cdd0171d1193
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Evolve Broach
• Version Model Number: 111-162-104
• 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	09348215002848 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133370

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[09348215002848]

Moist Heat or Steam Sterilization

[09348215002848]

Moist Heat or Steam Sterilization

[09348215002848]

Moist Heat or Steam Sterilization

[09348215002848]

Moist Heat or Steam Sterilization

[09348215002848]

Moist Heat or Steam Sterilization

[09348215002848]

Moist Heat or Steam Sterilization

[09348215002848]

Moist Heat or Steam Sterilization

[09348215002848]

Moist Heat or Steam Sterilization

[09348215002848]

Moist Heat or Steam Sterilization

[09348215002848]

Moist Heat or Steam Sterilization

[09348215002848]

Moist Heat or Steam Sterilization

[09348215002848]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-09-23
• Device Publish Date: 2019-10-09

On-Brand Devices [Evolve Broach]

• 09348215002855: 111-162-105
• 09348215002848: 111-162-104
• 09348215002831: 111-162-103
• 09348215002824: 111-162-102
• 09348215002817: 111-162-101