Isolite Mouthpiece

Basic Information

• Brand Name: Isolite Mouthpiece
• Primary DI: 00810032661250
• Version / Model: AIL0250
• Catalog Number: AIL0250
• Company Name: ZYRIS, INC.
• Labeler DUNS: 068038277
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-02
• Public Version: 1
• Public Version Date: 2024-05-10
• Public Version Status: New
• Public Device Record Key: 69bc5391-d1f9-4581-8b21-4390d6e492ae

Device Description

Customer Success Kit, OUS

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: 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIF	ACCESSORIES, RETRACTOR, DENTAL	Dental	872.4565	1
DYN	Mouthpiece, saliva ejector	Dental	872.6640	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
66751	Dental suction protective mouthpiece	A prefabricated device designed to be placed in the oral cavity during a dental procedure to protect the oral pathway by serving as a conduit for the continuous suction of debris/saliva, shielding the oral anatomy, maintaining an open mouth and retracted cheeks, and depressing the tongue. It is made of preformed materials for direct insertion into the mouth and includes features for connection to a dental suction unit. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810032661250	GS1

Customer Contacts

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

Storage Conditions

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