Origin DAA Broach

GUDID 09348215080426

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic broach

• Primary Device ID: 09348215080426
• NIH Device Record Key: 4dabb0a1-3b9f-4f67-825c-2b43b5ca66aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Origin DAA Broach
• Version Model Number: 111-39-3016
• 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	09348215080426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121297

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[09348215080426]

Moist Heat or Steam Sterilization

[09348215080426]

Moist Heat or Steam Sterilization

[09348215080426]

Moist Heat or Steam Sterilization

[09348215080426]

Moist Heat or Steam Sterilization

[09348215080426]

Moist Heat or Steam Sterilization

[09348215080426]

Moist Heat or Steam Sterilization

[09348215080426]

Moist Heat or Steam Sterilization

[09348215080426]

Moist Heat or Steam Sterilization

[09348215080426]

Moist Heat or Steam Sterilization

[09348215080426]

Moist Heat or Steam Sterilization

[09348215080426]

Moist Heat or Steam Sterilization

[09348215080426]

Moist Heat or Steam Sterilization

[09348215080426]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-29
• Device Publish Date: 2022-08-19

On-Brand Devices [Origin DAA Broach]

• 09348215080433: 111-39-3018
• 09348215080426: 111-39-3016
• 09348215080419: 111-39-3015
• 09348215080402: 111-39-3014
• 09348215080396: 111-39-3013
• 09348215080389: 111-39-3012
• 09348215080372: 111-39-3011
• 09348215080365: 111-39-3010
• 09348215080358: 111-39-3009
• 09348215080341: 111-39-3008