Universal 20-8000-020-02

GUDID 00889024304765

Orthosoft Inc

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00889024304765
• NIH Device Record Key: b0e24965-8e89-46ed-9cc5-4dc188f3ca34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal
• Version Model Number: 20-8000-020-02
• Catalog Number: 20-8000-020-02
• 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: 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
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)-348-2759
• Email: zimmer.consumerrelations@zimmer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024304765 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030827

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

[00889024304765]

Moist Heat or Steam Sterilization

[00889024304765]

Moist Heat or Steam Sterilization

[00889024304765]

Moist Heat or Steam Sterilization

[00889024304765]

Moist Heat or Steam Sterilization

[00889024304765]

Moist Heat or Steam Sterilization

[00889024304765]

Moist Heat or Steam Sterilization

[00889024304765]

Moist Heat or Steam Sterilization

[00889024304765]

Moist Heat or Steam Sterilization

[00889024304765]

Moist Heat or Steam Sterilization

[00889024304765]

Moist Heat or Steam Sterilization

[00889024304765]

Moist Heat or Steam Sterilization

[00889024304765]

Moist Heat or Steam Sterilization

[00889024304765]

Moist Heat or Steam Sterilization

[00889024304765]

Moist Heat or Steam Sterilization

[00889024304765]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-07

On-Brand Devices [Universal]

• 00889024304932: 20-8000-020-19
• 00889024304925: 20-8000-020-18
• 00889024304918: 20-8000-020-17
• 00889024304765: 20-8000-020-02