FDA.reportPublic FDA data

Winx®

Primary DI
00852126007506
Brand
Winx®
Company
APNICURE, INC.
Model
12215
Catalog number
12215
Device description
Winx Data Management Software on USB Drive
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OZRIntraoral Pressure Gradient Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZRIntraoral Pressure Gradient DeviceDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852126007506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852126007506008521260075068521260075060852126007506

GMDN Terms#

Term, Definition table
TermDefinition
Physician-practice-management information system application softwareAn application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data to support the administrative and clinical activities associated with the provision and utilization of physician services and office facilities. It may be used to process insurance claims and prepare patient statements; schedule the physician's time and make patient appointments; and store and retrieve patient records. It is typically installed into a dedicated information system for physician practice management, or existing mainframe or decentralized computers/networks.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888 986 6275poconnor@apnicure.com

Regulatory Flags#

DUNS number
008873230
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852126007018Winx®M1000-S1M1000-S12016-09-16
00852126007025Winx®M1000-S2M1000-S22016-09-16
00852126007032Winx®M1000-S3M1000-S32016-09-16
00852126007049Winx®M1000-M1M1000-M12016-09-16
00852126007056Winx®M1000-M2M1000-M22016-09-16
00852126007063Winx®M1000-M3M1000-M32016-09-16
00852126007070Winx®M1000-M4M1000-M42016-09-16
00852126007087Winx®M1000-L2M1000-L22016-09-16
00852126007094Winx®M1000-L3M1000-L32016-09-16
00852126007100Winx®M1000-L4M1000-L42016-09-16
00852126007117Winx®M5000-S1M5000-S12016-09-16
00852126007124Winx®M5000-S2M5000-S22016-09-16
00852126007131Winx®M5000-S3M5000-S32016-09-16
00852126007148Winx®M5000-M1M5000-M12016-09-16
00852126007155Winx®M5000-M2M5000-M22016-09-16
00852126007162Winx®M5000-M3M5000-M32016-09-16
00852126007179Winx®M5000-M4M5000-M42016-09-16
00852126007186Winx®M5000-L2M5000-L22016-09-16
00852126007193Winx®M5000-L3M5000-L32016-09-16
00852126007209Winx®M5000-L4M5000-L42016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719878320122iNAPSOMNICS, INC.OZR2024-02-05
04719878321525iNAPSOMNICS, INC.OZR2024-02-05
04719878321532iNAPSOMNICS, INC.OZR2024-02-05
04719878321099iNAP One SOMNICS, INC.OZR2023-03-07
04719878321105iNAP One SOMNICS, INC.OZR2023-03-07
04719878321075iNAP One SOMNICS, INC.OZR2023-03-06
04719878320856SomnicsSOMNICS, INC.OZR2022-11-28
04719878320108iNAP One SOMNICS, INC.OZR2022-06-15
04719878320528iNAP One SOMNICS, INC.OZR2022-06-15
04719878320535iNAP One SOMNICS, INC.OZR2022-06-15
04719878320542iNAP One SOMNICS, INC.OZR2022-06-15
04719878320023iNAPSOMNICS, INC.OZR2022-06-01
04719878320061iNAPSOMNICS, INC.OZR2022-06-01
04719878320559iNAPSOMNICS, INC.OZR2022-06-01
04719878320887iNAP One SOMNICS, INC.OZR2022-06-01
04719878320511iNAPSOMNICS, INC.OZR2021-07-21
04719878320184iNAPSOMNICS, INC.OZR2021-07-13
04719878320252iNAPSOMNICS, INC.OZR2021-06-03
04719878320047iNAPSOMNICS, INC.OZR2020-12-23
04719878320009iNAPSOMNICS, INC.OZR2020-09-23
04719878320030iNAPSOMNICS, INC.OZR2020-09-23
04719878320078iNAPSOMNICS, INC.OZR2020-09-23
04719878320092iNAPSOMNICS, INC.OZR2020-09-23
04719878320115iNAPSOMNICS, INC.OZR2020-09-23
00852126007001Winx®APNICURE, INC.OZR2016-09-16
00852126007018Winx®APNICURE, INC.OZR2016-09-16
00852126007025Winx®APNICURE, INC.OZR2016-09-16
00852126007032Winx®APNICURE, INC.OZR2016-09-16
00852126007049Winx®APNICURE, INC.OZR2016-09-16
00852126007056Winx®APNICURE, INC.OZR2016-09-16