20/20™

Basic Information

• Brand Name: 20/20™
• Primary DI: 10810000527585
• Version / Model: S475
• Catalog Number: S475
• Company Name: PARKELL, INC.
• Labeler DUNS: 009900424
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2019-08-30
• Public Version: 3
• Public Version Date: 2024-01-29
• Public Version Status: Update
• Public Device Record Key: 98cda766-62c2-41a8-980c-2a005b51b32c

Device Description

20/20™ Double Sided Mouth Mirrors (Pkg. of 6 pcs.)

Device Characteristics

• Single Use: No
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
EAX	Mirror, Mouth	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31776	Dental mirror, reusable	A hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10810000527585	GS1
Unit of Use	00810000527588	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do Not Clean Ultrasonically. Do Not use Dry Heat for sterilization. Do Not subject mirrors to temperatures above 180C.