HYGITECH

Primary DI
03615140002479
Brand
HYGITECH
Company
HYGITECH
Model
HY-0861
Catalog number
HY-0861
Device description
The IMPLANFIELD kit is designed for protecting the operating theatre. It is recommended for surgeries that are not implantology- or endodontology-specific. Indeed, these surgeries do not usually require an operating room meaning there are more surfaces to cover. The kit is composed of 25 items: 1 4 Polyethylene gloves 2 1 Plastic bag (50x80cm) 3 2 Adhesive films (5x80cm) 4 1 Tube support with adhesive 5 3 Protective sleeves for tubing (8x120cm) 6 1 Adhesive protective cover for control panel 7 2 Elastic cap handle covers 8 1 Protective PVC X-ray cover 9 2 Surgical drapes (75x75cm) 10 1 Instrument table cover (90x120cm) 11 1 Instrument table cover (bridge) (100x180cm) 12 1 Surgical drape with aperture and adhesive (75x90cm) 13 1 U-shaped surgical drape with adhesive (100x150cm) 14 3 Non-latex elastic bands 15 1 Wrapping paper The IMPLANFIELD kit is complementary to the IMPLANWEAR kit, which contains all clothing protection for the operation. The materials # Polypropylene non woven fabric # Laminated non-woven fabric # SMS Microfibre # Crepe paper
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
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
03615140002479PackageGS15Not in Commercial Distribution
03615140002462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03615140002479036151400024793615140002479
03615140002462036151400024623615140002462

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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