HYGITECH

Basic Information

• Brand Name: HYGITECH
• Primary DI: 03615140000383
• Version / Model: HY-07015
• Catalog Number: HY-07015
• Company Name: HYGITECH
• Labeler DUNS: 279456896
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-15
• Public Version: 1
• Public Version Date: 2020-12-23
• Public Version Status: New
• Public Device Record Key: 99797730-8bde-4207-a0a7-e32914914924

Device Description

Protective glasses for both the dentist and the patient, ideal during polymerisation of dental pulp. • Perfect protection: protects against splashes, UV rays (efficient against the UVC) and blue light, improves contrast and reduces eye fatigue • Full lateral protection • Single-piece frame for the best eye protection • Can be worn alone or over glasses. • Anti-fog and anti-scratch treatment on the inside and front of glasses • Provides comfort during procedures : doesn’t affect vision during a procedure • Dimensions: 19cm width x 7cm height • Light weight: 36 g

Device Characteristics

• Single Use: No
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	886.4750	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35736	Ultraviolet view box	A mains electricity (AC-powered) device designed for visual examination of a process and/or its results using ultraviolet (UV) light. It is used to support and illuminate an object with UV light so that the information held within this object can be seen and studied. It typically includes UV lamps of one or more frequencies (254, 312, and 366 nm are typical), a translucent diffusing screen, and filters; the illumination typically comes from behind the object being viewed. It is mainly used in clinical laboratories for visual examination of a process and/or its results (e.g., for assessing thin-layer chromatographs, electrophoresis gels); but is also used in photo documentation processes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03615140000390	GS1	Carton	100	In Commercial Distribution
Primary	03615140000383	GS1