ZAVATION

Basic Information

• Brand Name: ZAVATION
• Primary DI: 00842166117501
• Version / Model: 95-4512
• Catalog Number: NA
• Company Name: ZAVATION LLC
• Labeler DUNS: 069472800
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-06
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 385b2aa5-caa8-4e3a-a840-e9f0ab19f110

Device Description

Polyaxial Screw 4.5mm x 12mm

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
NKG	Orthosis, Cervical Pedicle Screw Spinal Fixation	Orthopedic	888.3075	2
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	888.3050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61306	Microplate seal roller IVD	A manually-operated device intended to firmly apply a seal to a microplate. It consists of a cylindrical-shaped roller attached to a handle and is typically made of metal and plastic materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842166117501	GS1

Customer Contacts

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