Zyris, Isolite Mouthpiece

Basic Information

• Brand Name: Zyris, Isolite Mouthpiece
• Primary DI: 00810032660178
• Version / Model: CIL0801
• Catalog Number: CIL0801
• Company Name: ZYRIS, INC.
• Labeler DUNS: 068038277
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-09-24
• Public Version: 1
• Public Version Date: 2019-10-02
• Public Version Status: New
• Public Device Record Key: 98c1fa3e-28a7-404e-be39-751229c02669

Device Description

Mouthpiece, 10-Pack, Medium DV

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
EIF	ACCESSORIES, RETRACTOR, DENTAL	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13380	Hand-held dental retractor	A hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. It is typically a metallic device and includes a shaped/hooked blade with a handle/holding portion. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810032660178	GS1
Unit of Use	10810032660175	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 55 Degrees Celsius