OriginPlus Broach

GUDID 09348215081119

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic broach

• Primary Device ID: 09348215081119
• NIH Device Record Key: 472aca52-ac8e-4abc-bf40-d3a155f3cf14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OriginPlus Broach
• Version Model Number: 112-44-1017
• 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	09348215081119 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201951

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[09348215081119]

Moist Heat or Steam Sterilization

[09348215081119]

Moist Heat or Steam Sterilization

[09348215081119]

Moist Heat or Steam Sterilization

[09348215081119]

Moist Heat or Steam Sterilization

[09348215081119]

Moist Heat or Steam Sterilization

[09348215081119]

Moist Heat or Steam Sterilization

[09348215081119]

Moist Heat or Steam Sterilization

[09348215081119]

Moist Heat or Steam Sterilization

[09348215081119]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-15
• Device Publish Date: 2022-07-07

On-Brand Devices [OriginPlus Broach]

• 09348215081126: 112-44-1018
• 09348215081119: 112-44-1017
• 09348215081102: 112-44-1016
• 09348215081096: 112-44-1015
• 09348215081089: 112-44-1014
• 09348215081072: 112-44-1013
• 09348215081065: 112-44-1012
• 09348215081058: 112-44-1011
• 09348215081041: 112-44-1010
• 09348215081034: 112-44-1009
• 09348215081027: 112-44-1008
• 09348215081010: 112-44-1007
• 09348215081003: 112-44-1006