FDA.reportPublic FDA data

HYGITECH

Primary DI
03615140002592
Brand
HYGITECH
Company
HYGITECH
Model
HY-130025
Catalog number
HY-130025
Device description
Comprehensive examination kit: a ready-to-use tray for all kinds of proceduresContents: 1 mouth mirror, 1 probe, 1 pair of tweezers, 1 ear-loop mask, 1 tissue, 2 cotton rolls, 1 spatula, 1 saliva pump.
Published
2020-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
03615140002608PackageGS110In Commercial Distribution
03615140002615PackageGS110In Commercial Distribution
03615140002592PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03615140002608036151400026083615140002608
03615140002615036151400026153615140002615
03615140002592036151400025923615140002592

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Regulatory Flags#

DUNS number
279456896
Device count
1
Premarket exempt
true
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
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
03615140003216HYGITECHHY-60035HY-600352020-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G879102GS10DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102GS20DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102GS30DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102GS40DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102GS50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102GS60DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102H1H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102H2H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102H3H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G149TBSB4010TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4020TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4030TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4040TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4050TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4060TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4070TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4080TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4140TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4150TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4200TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4210TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4220TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB8130TBS BASICSACME ENTERPRISE.EIY2026-05-18
G149TBSB8010TBS BASICSACME ENTERPRISE.EIY2026-05-17
G149TBSB8020TBS BASICSACME ENTERPRISE.EIY2026-05-17
G149TBSB8030TBS BASICSACME ENTERPRISE.EIY2026-05-17
G149TBSB8040TBS BASICSACME ENTERPRISE.EIY2026-05-17
G149NPBPT0NPSACME ENTERPRISE.EIY2026-05-01
08800075626134OSUNG MNDOSUNG MND Co., Ltd.EIY2025-11-03
07649988072451OdneFill TipOdne AGEIY2024-02-01