FDA.reportPublic FDA data

HYGITECH

Primary DI
03615140003872
Brand
HYGITECH
Company
HYGITECH
Model
HY-05902
Catalog number
HY-05902
Device description
Sterile transparent drape with adhesive HYGITECH Reference: HY-05902 Practical for all surgeries, the transparent sterile drape with adhesive allows the protection of the implantology motor or the control unit without compromising the sterility of the surgery. The transparency ensures you can keep an eye on the indications shown on the screen and easily change the programme. More info Characteristics : • 1 waterproof layer of polyethylene (65g/m²) • Dimensions: 40 (width) cm x 50 (length) cm • Adhesive: Located along the width of the drape(40 x 5 cm) Waterproof protection of surfaces -Effective barrier to fight against cross contaminations in non autoclavable elements. - Protection against bacteria and viruses, it allows to limit the use of disinfectants and makes the equipment last longer Solidity - Resistant, does not tear
Published
2020-12-15
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
KKXDrape, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03615140003872PackageGS125In Commercial Distribution
03615140003889PackageGS14In Commercial Distribution
03615140003865PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03615140003872036151400038723615140003872
03615140003889036151400038893615140003889
03615140003865036151400038653615140003865

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drape adhesiveA spray, typically aerosol, intended to be applied to the skin to cause a surgical drape to adhere to the body. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
279456896
Device count
1
DM exempt
false
Premarket exempt
false
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
08056646500291Basic Implant SetOMNIA SRLKKX2026-03-27
08056646500307Implantology SetOMNIA SRLKKX2026-03-27
08056646500321Oral Surgery SetOMNIA SRLKKX2026-03-27
08056646500482Oral Surgery PackOMNIA SRLKKX2026-03-27
10812564036022MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036077MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036107MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036183MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036190MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036213MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036381MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20080196017017MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277636726MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277660943MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277660950MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
40884389185781MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277635552MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
40888277357038MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
10080196176700Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496648Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496655Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496686Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497164Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497171Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497188Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497195Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497720Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497744Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498239Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498376Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29