HYGITECH

Primary DI
03615140005142
Brand
HYGITECH
Company
HYGITECH
Model
HY-0921
Catalog number
HY-0921
Device description
Start kit HYGITECH Reference: HY-0921 The START kit is a great starter kit for light or heavy implantology procedures. Each kit contains 32 separate items: 4 Polyethylene gloves 2 tie-on masks 2 surgical hats 1 Bouffant cap 1 Pair of overshoes 1 Patient gown with cotton cuffs 2 Protective sleeves for tubing (3.5" x 47" / 8 x 120 cm) 1 ice bag 1 surgical drape with adhesive (39" x 39" / 100x100cm) 1 surgical drape with aperture (27.5" x 31.5" / 70 x 80cm) 2 Elastic cap handle covers 1 saliva ejector 1 non-latex elastic band 1 surgical drape with adhesive (59" x 59" / 150x150cm) 1 tube support with adhesive 1 surgical brush with nail cleaner 4 Paper hand-towels 2 surgical gowns with cotton cuffs 1 Wrapping paper
Published
2020-12-16
Public version status
New
Distribution status
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
KDDKit, Surgical Instrument, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03615140005142PackageGS15In Commercial Distribution
03615140005135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03615140005142036151400051423615140005142
03615140005135036151400051353615140005135

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

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Primary DI, Brand, Company table
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00749756401708DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-18
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08906039319736OSSEOUS Myringotomy Kit-Pediatric EON MEDITECH PRIVATE LIMITEDKDD2024-07-04
10192253065442Aero-MedAERO-MED, LLCKDD2024-03-11
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10195327266271Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-03-05
10195327271633Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-12-18
10885380194108Aero-MedAERO-MED, LLCKDD2022-12-15