Venus

Basic Information

• Brand Name: Venus
• Primary DI: 00840916118952
• Version / Model: VSV4020
• Company Name: SPINAL ELEMENTS
• Labeler DUNS: 004022104
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-25
• Public Version: 4
• Public Version Date: 2020-03-24
• Public Version Status: Update
• Public Device Record Key: 873f2563-a89b-45e5-a385-35c0c10c6a6c
• Distribution End Date: 2020-03-23

Device Description

Venus Cervical Variable Screw, 4.0 x 20mm

Device Characteristics

• Single Use: Yes
• 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: No
• 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
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	888.3060	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61865	Cervical total disc replacement prosthesis, non-sterile	A non-sterile implantable device designed to replace most or all of a dysfunctional intervertebral disc in the cervical spine. It is made of synthetic polymer material(s) [e.g., polyetheretherketone (PEEK)] and typically has a two-plate design, one plate attaching to the vertebra above and the other to the vertebra below, to facilitate motion usually through the sliding action of its smooth surfaces. This device is intended to be sterilized before use.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840916118952	GS1