Medacta Broach Handle 01.10.10.461

GUDID 00854515008293

Unique Surgical

Surgical retraction system, single-use

• Primary Device ID: 00854515008293
• NIH Device Record Key: a9ea70c9-9ad2-4f5f-ad53-d9f0cdc6fdd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medacta Broach Handle
• Version Model Number: Left, Zimmer Style
• Catalog Number: 01.10.10.461
• Company DUNS: 079820535
• Company Name: Unique Surgical
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 818-813-8527
• Email: info@UniqueSurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854515008293 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00854515008293]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-01-13
• Device Publish Date: 2023-01-05

On-Brand Devices [Medacta Broach Handle]

• 00854515008293: Left, Zimmer Style
• 00854515008286: Right, Zimmer Style