Origin Broach

GUDID 09348215039691

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic broach

• Primary Device ID: 09348215039691
• NIH Device Record Key: ba550902-3013-4fcf-98d0-9e1e92a9d4fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Origin Broach
• Version Model Number: 111-18-0809
• 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	09348215039691 [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

[09348215039691]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-04
• Device Publish Date: 2018-10-02

On-Brand Devices [Origin Broach]

• 09348215039783: 111-18-1809
• 09348215039776: 111-18-1609
• 09348215039769: 111-18-1509
• 09348215039752: 111-18-1409
• 09348215039745: 111-18-1309
• 09348215039738: 111-18-1209
• 09348215039721: 111-18-1109
• 09348215039714: 111-18-1009
• 09348215039707: 111-18-0909
• 09348215039691: 111-18-0809
• 09348215039684: 111-18-0609