FDA.reportPublic FDA data

Luxisse

Primary DI
00817724022894
Brand
Luxisse
Company
HEANY INDUSTRIES, INC.
Model
D
Catalog number
MDDK3702ZF12A2
Device description
Yttria stabilized Zirconia Disk
Published
2019-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NIHDisinfectant, Subsystem, Water Purification

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIHDisinfectant, Subsystem, Water PurificationGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817724022894PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817724022894008177240228948177240228940817724022894

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter94Millimeter
Width12Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5858892700cliffr@heany.com

Regulatory Flags#

DUNS number
002221091
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817724029039Luxisse0MDDK3702ZF30B12023-08-07
00817724029022Luxisse0MDDK3701ZF10B22023-07-31
00817724028995LUXISSEBMD DK 0639 002022-11-01
00817724029008LUXISSEBMD DK 0639 202022-11-01
00817724029015LUXISSEBMD DK 0639 302022-11-01
00817724028933LUXISSE0MDDK3701ZF10A352022-10-24
00817724028940LUXISSE0MDDK3701ZF10A42022-10-24
00817724028957LUXISSE0MDDK3701ZF10C12022-10-24
00817724028964LUXISSE0MDDK3701ZF10C32022-10-24
00817724028971LUXISSE0MDDK3701ZF10C42022-10-24
00817724028988LUXISSE0MDDK3701ZF10D42022-10-24
00817724028926LUXISSEBMD DK 0639 012022-04-27
00817724028919LUXISSEEMDDK3702ZF30OM32022-02-28
00817724028865Luxisse0MDDK3701ZF10A32022-01-31
00817724028872Luxisse0MDDK3701ZF10B12022-01-31
00817724028889LUXISSE0MDDK3701ZF10C22022-01-31
00817724028896LUXISSE0MDDK3701ZF10D22022-01-31
00817724028902Luxisse0MDDK3701ZF10D32022-01-31
00817724028841Luxisse0MDDK3701ZF10A22021-03-23
00817724028834Luxisse0MDDK3701ZF10A12021-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995223298Minncare HDMEDIVATORS INC.NIH2024-03-26
50724995223293Minncare HDMEDIVATORS INC.NIH2024-03-26
00854001007564SPRINTSPR THERAPEUTICS, INC.NIH2018-09-14
00677964066863Minncare HDMEDIVATORS INC.NIH2018-01-09
00677964066870Minncare HDMEDIVATORS INC.NIH2018-01-09
00677964079498Minncare HDMEDIVATORS INC.NIH2018-01-09
30677964066888Minncare HD Residual Test StripsMEDIVATORS INC.NIH2018-01-09
30677964066895Minncare HD 1% Indicator Test StripsMEDIVATORS INC.NIH2018-01-09
30677964066864Minncare HDMEDIVATORS INC.NIH2018-01-09
30677964066871Minncare HDMEDIVATORS INC.NIH2018-01-09
30677964079499Minncare HDMEDIVATORS INC.NIH2018-01-09