Bigliani/Flatow 20-8075-007-02

GUDID 00889024304161

Orthosoft Inc

Orthopaedic implant aiming arm

• Primary Device ID: 00889024304161
• NIH Device Record Key: bf482ba0-e2fa-4646-b0f5-ad93e94c4a2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bigliani/Flatow
• Version Model Number: 20-8075-007-02
• Catalog Number: 20-8075-007-02
• Company DUNS: 205670032
• Company Name: Orthosoft Inc
• 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: true
• 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

Customer Support Contacts

• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024304161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150730

FDA Product Code

• PBF: Orthopaedic Surgical Planning And Instrument Guides

Sterilization

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

[00889024304161]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-09-12

On-Brand Devices [Bigliani/Flatow]

• 00889024304161: 20-8075-007-02
• 00889024304154: 20-8075-007-01