iSmile

Basic Information

• Brand Name: iSmile
• Primary DI: 00816419021648
• Version / Model: 25-5004
• Catalog Number: 25-5004
• Company Name: Ismile Dental Products, Inc.
• Labeler DUNS: 016765988
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2023-06-21
• Public Version: 1
• Public Version Date: 2023-06-29
• Public Version Status: New
• Public Device Record Key: b0331641-6040-4e34-9f14-54c816f14e66

Device Description

Tray Cover Ritter (B) 8-1/2" x 12-1/4" Lavender

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NRU	Chair, Dental, Without Operative Unit	Dental	872.6250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64367	Instrument tray cover, single-use	A flexible, synthetic polymer cover designed to be placed on an instrument tray to provide a protective barrier for the transport and short-term storage of clinical instruments (typically endoscopes or surgical instruments). It is typically available in two colours to indicate clean/sterile or contaminated; a tray liner is typically supplied with the device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	20816419021642	GS1
Primary	00816419021648	GS1

Customer Contacts

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