Isovac2

Basic Information

• Brand Name: Isovac2
• Primary DI: 00810032660338
• Version / Model: EIV0202
• Catalog Number: EIV0202
• Company Name: ZYRIS, INC.
• Labeler DUNS: 068038277
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2024-04-08
• Public Version: 3
• Public Version Date: 2025-01-31
• Public Version Status: Update
• Public Device Record Key: 72d67132-e809-4268-b490-ad25de1facdb

Device Description

Isovac2, 3-Pack

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• 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
EBR	UNIT, SUCTION OPERATORY	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34859	Dental suction system	An assembly of devices designed to aspirate water, blood, saliva, and tooth debris from the oral cavity by means of suction, to maintain a clear operative site during dental surgical, professional hygiene, and orthodontic procedures. It consists of an electrically-powered suction pump with a control knob and patient contact devices (typically suction handpiece/tip); collection containers, spittoon, tubing, and amalgam separator are also often included.	No	Active
44827	Dental dry field kit	A collection of devices and supplies used in orthodontic and restorative dentistry to maintain a dry oral cavity for treatment procedures. It provides the operator with easy access to the field of operation by holding the mouth open, displacing the tongue, and removing saliva during various procedures (e.g., bonding orthodontic brackets, bleaching, applying veneers or pit and fissure sealants, posterior restorations). It typically consists of bite blocks, pad extenders, suction tips of varying sizes, and tubing that connects to a suction system. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10810032660335	GS1
Primary	00810032660338	GS1

Customer Contacts

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