FDA.reportPublic FDA data

HYGITECH

Primary DI
03615140002769
Brand
HYGITECH
Company
HYGITECH
Model
HY-130010
Catalog number
HY-130010
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°)
Published
2020-11-24
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EIYInstrument, Filling, Plastic, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIYInstrument, Filling, Plastic, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03615140002769PackageGS120Not in Commercial Distribution
03615140002776PackageGS130Not in Commercial Distribution
03615140002752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03615140002769036151400027693615140002769
03615140002776036151400027763615140002776
03615140002752036151400027523615140002752

GMDN Terms#

Term, Definition table
TermDefinition
Denture repair kit, professionalA 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.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454001530COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001547COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001554COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001608COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001622COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001639COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001646COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001660COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001677COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454002216COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454002667COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454002674COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454004203COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454004210COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454007310COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454010815COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454010822COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454010839COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454010846COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454011584COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454011744COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454012086COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454012949COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454012956COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454013137COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454014516COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454015896COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454015902COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454015919COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454015926COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26