TSI Stem Broach

GUDID 09348215040529

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic broach

• Primary Device ID: 09348215040529
• NIH Device Record Key: fcd9fbdd-6afb-4325-95d5-687ea6a4e506
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TSI Stem Broach
• Version Model Number: 112-28-0044
• 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	09348215040529 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181340

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[09348215040529]

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 [TSI Stem Broach]

• 09348215040529: 112-28-0044
• 09348215040512: 112-28-0043
• 09348215040505: 112-28-0008
• 09348215040499: 111-23-2050
• 09348215040482: 111-23-2040
• 09348215040475: 111-23-2030
• 09348215040468: 111-23-2020
• 09348215040451: 111-23-2010
• 09348215040444: 111-23-2000