HYGITECH

Primary DI
03615140000390
Brand
HYGITECH
Company
HYGITECH
Model
HY-07015
Catalog number
HY-07015
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
Published
2020-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03615140000390PackageGS1100In Commercial Distribution
03615140000383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03615140000390036151400003903615140000390
03615140000383036151400003833615140000383

GMDN Terms#

Term, Definition table
TermDefinition
Ultraviolet view boxA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
279456896
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03615140002875HYGITECHHY-064HY-0642020-12-15
03615140002899HYGITECHHY-066HY-0662020-12-15
03615140003247HYGITECHHY-50013HY-500132020-12-15
03615140003568HYGITECHHY-50018HY-500182020-12-15
03615140003612HYGITECHHY-50016HY-500162020-12-15
03615140003728HYGITECHHY1-630HY1-6302020-10-13
03615140000116HYGITECHHY-90078HY-900782020-12-14
03615140000307HYGITECHHY-057HY-0572020-12-15
03615140000321HYGITECHHY-055HY-0552020-12-15
03615140002721HYGITECHHY-05702HY-057022020-12-15
03615140002837HYGITECHHY-060HY-0602020-12-15
03615140002851HYGITECHHY-062HY-0622020-12-15
03615140002561HYGITECHHY-130012HY-1300122020-11-24
03615140002592HYGITECHHY-130025HY-1300252020-12-15
03615140004534HYGITECHHY-130014HY-1300142020-12-16
03615140003261HYGITECHHY-50015HY-500152020-12-15
03615140003094HYGITECHHY-525HY-5252020-11-25
03615140003124HYGITECHHY-604HY-6042020-11-25
03615140003155HYGITECHHY-607HY-6072020-11-25
03615140003186HYGITECHHY-60033HY-600332020-11-25

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D125720TR4Premium PlusPremium Plus (Dongguan) LimitedHOY2026-06-09
00757770535583Bausch + LombBausch & Lomb IncorporatedHOY2026-04-30
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