EFFDNT DENT BATH KIT 1CT

Basic Information

• Brand Name: EFFDNT DENT BATH KIT 1CT
• Primary DI: 00814832011093
• Version / Model: 10814832011090
• Company Name: Medtech Products Inc.
• Labeler DUNS: 060272465
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-30
• Public Version: 2
• Public Version Date: 2023-07-03
• Public Version Status: Update
• Public Device Record Key: 56823df6-408e-4231-8a85-665a959a694b

Device Description

EFERDENT DENT BATH KIT 1CT

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
JER	Cleaner, Denture, Mechanical	Dental	872.3530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35871	Denture cleanser	An agent intended to be used to remove soft debris from removable prosthetic dental appliances (e.g., dentures or bridges), normally by the immersion of the prosthesis/appliance in the agent overnight and/or mechanical cleaning with a toothbrush. It is intended for home-use and/or for hospitalized or institutionalized patients. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814832011093	GS1

Customer Contacts

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