Trial Neck Reacher 37.5-50

GUDID 09348215055530

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215055530
• NIH Device Record Key: 1f4c8040-fec5-4447-889f-ace638fb5a61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trial Neck Reacher 37.5-50
• Version Model Number: 111-242-153
• 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	09348215055530 [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

[09348215055530]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-07
• Device Publish Date: 2019-10-30

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• 09348215135393 - World Cup Liner – Neutral Lateralised: 2024-12-11
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• 09348215135430 - World Cup Liner – Neutral Lateralised: 2024-12-11