N/A 20-8012-010-22

GUDID 00889024355835

SYNVASIVE TECHNOLOGY, INC.

Knee arthroplasty force sensor balance kit

• Primary Device ID: 00889024355835
• NIH Device Record Key: 51e53ed2-e398-4e7b-8fa2-37636cdca1a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 20-8012-010-22
• Catalog Number: 20-8012-010-22
• 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	00889024355835 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00889024355835]

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 [N/A]

• 00889024355835: 20-8012-010-22
• 00889024367289: Full Length Sling