eLIBRA®

GUDID 00889024355590

SYNVASIVE TECHNOLOGY, INC.

Knee arthroplasty force sensor balance kit

• Primary Device ID: 00889024355590
• NIH Device Record Key: 35dc90ab-4411-4c7b-a420-82a582dacd2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eLIBRA®
• Version Model Number: 20-8012-000-01
• Company DUNS: 618258974
• Company Name: SYNVASIVE TECHNOLOGY, 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024355590 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070108

FDA Product Code

• ONN: Intraoperative Orthopedic Joint Assessment Aid

Sterilization

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

Device Entry Metadata

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

On-Brand Devices [eLIBRA® ]

• 00889024355934: 20-8012-010-32
• 00889024355927: 20-8012-010-31
• 00889024355910: 20-8012-010-30
• 00889024355903: 20-8012-010-29
• 00889024355897: 20-8012-010-28
• 00889024355873: 20-8012-010-26
• 00889024355828: 20-8012-010-21
• 00889024355811: 20-8012-010-19
• 00889024355804: 20-8012-010-18
• 00889024355798: 20-8012-010-17
• 00889024355781: 20-8012-010-16
• 00889024355774: 20-8012-010-15
• 00889024355767: 20-8012-010-14
• 00889024355750: 20-8012-010-13
• 00889024355743: 20-8012-010-12
• 00889024355736: 20-8012-010-11
• 00889024355729: 20-8012-010-10
• 00889024355712: 20-8012-010-09
• 00889024355606: 20-8012-000-02
• 00889024355590: 20-8012-000-01