DENTAL PACK

Basic Information

• Brand Name: DENTAL PACK
• Primary DI: M75257029411
• Version / Model: 570-2941
• Company Name: STRADIS MEDICAL LLC
• Labeler DUNS: 043537671
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-28
• Public Version: 1
• Public Version Date: 2022-04-05
• Public Version Status: New
• Public Device Record Key: 207dbd9d-99cd-49dc-bc96-d447004d139f

Device Description

DENTAL TRAINING PACK

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
OFX	General Purpose Dental Tray	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12304	Oral lavage system	An assembly of devices intended for automated or semi-automated irrigation and washing of tissue/debris from teeth, gums, and other parts of the oral cavity (e.g., tongue) through application of pulsed jets of non-medicated liquids (e.g., mouthwash, water), to maintain oral hygiene; it may in addition be intended for nasal lavage. It consists of a central mains electricity (AC-powered) unit with a reservoir and pump, and a number of hand-held applicators, each typically designed to clean a specific oral anatomy (e.g., tongue, braces, gum line). It is normally available [non-prescription] over-the-counter (OTC) for use in the home and dental office.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M75257029411	HIBCC

Customer Contacts

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