iASSIST® 20-8011-070-01

GUDID 00889024305502

Orthosoft Inc

Orthopaedic stereotactic surgery system

• Primary Device ID: 00889024305502
• NIH Device Record Key: 99c4a3c9-5978-40db-9325-c68575e53c66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iASSIST®
• Version Model Number: 20-8011-070-01
• Catalog Number: 20-8011-070-01
• 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: 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

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024305502 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122326

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-15
• Device Publish Date: 2016-09-07

On-Brand Devices [iASSIST®]

• 00889024563490: 20-8011-070-19
• 00889024563483: 20-8011-070-24
• 00889024305502: 20-8011-070-01