eLIBRA®

Basic Information

• Brand Name: eLIBRA®
• Primary DI: 00889024355804
• Version / Model: 20-8012-010-18
• Catalog Number: 20-8012-010-18
• Company Name: SYNVASIVE TECHNOLOGY, INC.
• Labeler DUNS: 618258974
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-07
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 28773c72-cb18-482d-a567-e70fe0152110

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58989	Knee arthroplasty force sensor balance kit	A collection of non-sterile devices intended for use with a knee arthroplasty force sensor to measure forces acting across the joint to facilitate assessment of bone resection lines and size of prosthesis components to be implanted. It is intended to help achieve correct femoral rotation, flexion stability, proper patella tracking, and/or medial-lateral ligament balance. It typically consists of femoral components, tibial spacers, positioning guides, fixation screws, and an adjustment wrench. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00889024355804	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Large
Height	13	Millimeter