HYGITECH

Basic Information

• Brand Name: HYGITECH
• Primary DI: 03615140002752
• Version / Model: HY-130010
• Catalog Number: HY-130010
• Company Name: HYGITECH
• Labeler DUNS: 279456896
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-24
• Public Version: 2
• Public Version Date: 2020-12-15
• Public Version Status: Update
• Public Device Record Key: 1335c0be-d6d2-4698-8158-260c621c6cf1

Device Description

Single use sterile mirror, 21mm diameter with anti-fog treatment. Handle length: 14 cm. Advantages: - Bright and brilliant reflexion: The mirror is made of rhodium, thus the image is reflected only once. - Convenient: Ideal angulation (30°)

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: 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIY	Instrument, Filling, Plastic, Dental	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11171	Denture repair kit, professional	A collection of devices used in dentistry by a dentist or dental laboratory technician to repair cracks or breaks in a denture. It will contain the necessary materials and components, e.g., resins, adhesives/glues, mixing utensils, and an applicator. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03615140002769	GS1	Box	20	In Commercial Distribution
Primary	03615140002752	GS1
Package	03615140002776	GS1	Carton	30	In Commercial Distribution