HYGITECH

Primary DI
03615140000178
Brand
HYGITECH
Company
HYGITECH
Model
HY-07104
Catalog number
HY-07104
Device description
The HYGITECH loupe is an optical instrument developed to facilitate visualisation of specific objects or areas. It was conceived for all precise work as well as helping improve performance of dental surgeons during technical procedures.Characteristics :• A Velcro strap allows comfortable adjustment of the loupe around the head• The loupe can be moved up and down to better align the eyes with the magnified area• The unbreakable lenses protect the eyes, help your eyes adjust quickly and comfortably and give the exact hue of the magnified object• Available in two magnifications, x2.5 or x3.5Ergonomic - Perfectly adjustable around the head, the loupe’s ergonomics offer true comfort and incomparable ease of use.Light- Weighing only 70g, the HYGITECH loupe is remarkably light.Practical- Allowing assistance during technical procedures, the loupe helps give the dental surgeon a better approach to the surgical field
Published
2020-12-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173062000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173062000Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))V&Q Manufacturing Corporation2018-01-25FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03615140000185PackageGS112In Commercial Distribution
03615140000178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03615140000185036151400001853615140000185
03615140000178036151400001783615140000178

GMDN Terms#

Term, Definition table
TermDefinition
Lens loop, reusableA hand-held, manual, ophthalmic surgical instrument designed for eye lens extraction and gentle manipulation and/or irrigation of eye tissues during an ophthalmic surgical procedure. It typically consists of a small wire loop (frequently serrated) at the distal tip and a handle for easy manipulation; it may also include a channel (e.g., a cannula) which is connected to an external irrigator for irrigation of the eye. This is a reusable device.

Regulatory Flags#

DUNS number
279456896
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
No natural rubber latex
true

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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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16980077680101AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680118AOKAOK TOOLING LIMITEDFXX2026-06-03
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16980077680132AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680071AOKAOK TOOLING LIMITEDFXX2026-05-28
16980077680088AOKAOK TOOLING LIMITEDFXX2026-05-28
16980077680095AOKAOK TOOLING LIMITEDFXX2026-05-28
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10097604555514Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2025-07-28
10371347011606Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
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10097604543320Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
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