LIBRA 20-8012-001-02

GUDID 00889024430112

SYNVASIVE TECHNOLOGY, INC.

Knee arthroplasty force sensor balance kit

• Primary Device ID: 00889024430112
• NIH Device Record Key: 3c6e1165-1c74-4579-bf1b-e2323b9bd5f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIBRA
• Version Model Number: 20-8012-001-02
• Catalog Number: 20-8012-001-02
• Company DUNS: 618258974
• Company Name: SYNVASIVE TECHNOLOGY, INC.
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024430112 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00889024430112]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-07-07

On-Brand Devices [LIBRA]

• 00889024430129: 20-8012-001-03
• 00889024430112: 20-8012-001-02
• 00889024430105: 20-8012-001-01
• 00889024430099: 20-8012-001-00
• 00889024355880: 20-8012-010-27
• 00889024355866: 20-8012-010-25
• 00889024355859: 20-8012-010-24
• 00889024355842: 20-8012-010-23
• 00889024355705: 20-8012-010-08
• 00889024355682: 20-8012-010-06
• 00889024355675: 20-8012-010-05
• 00889024355668: 20-8012-010-04
• 00889024355651: 20-8012-010-03
• 00889024355644: 20-8012-010-02
• 00889024355637: 20-8012-010-01