FDA.reportPublic FDA data

Flow Dental

Primary DI
08717228442537
Brand
Flow Dental
Company
DuPhaMed B.V.
Model
Earflow34
Catalog number
81500
Device description
Confee Ears Disposable ear sleeves for CBCT exams
Published
2023-11-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EGZHolder, Film, X-Ray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGZHolder, Film, X-RayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717228442537PrimaryGS10
08717228441011Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717228442537087172284425378717228442537
08717228441011087172284410118717228441011

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Regulatory Flags#

DUNS number
413491023
Device count
150
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717228440113DenBiteDBBBLS2023-11-24
08717228440120DenBiteDBU30012023-11-24
08717228440137DenBiteDBS012023-11-24
08717228440144DenBiteDBS022023-11-24
08717228440212DenBiteDBU34ES2023-11-24
08717228440366CeflaCEF4060979018602023-11-23
08717228440373CeflaCEF4061979018612023-11-23
08717228440380CeflaCEF4062979018622023-11-23
08717228440397CeflaCEF4063979018632023-11-23
08717228440403CeflaCEF4064966093472023-11-23
08717228440410CeflaCEFQRBBLS979014842023-11-23
08717228440427CeflaCEFS01979011132023-11-23
08717228440434CeflaCEFS02979011142023-11-23
08717228440458CeflaCEFFOAM979015572023-11-23
08717228440557Care Stream DentalBDA32BDA322023-11-23
08717228440564Care Stream DentalBDA33BDA332023-11-23
08717228440571Care Stream DentalIX014IX0142023-11-23
08717228440588Care Stream DentalIX015IX0152023-11-23
08717228440595Care Stream DentalIX016IX0162023-11-23
08717228442605Care Stream Dental7200 #059425032023-11-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456221891JMUJMU DENTAL, INCEGZ2026-06-08
00840456221907JMUJMU DENTAL, INCEGZ2026-06-08
00840456221914JMUJMU DENTAL, INCEGZ2026-06-08
00840456221921JMUJMU DENTAL, INCEGZ2026-06-08
00840456221938JMUJMU DENTAL, INCEGZ2026-06-08
00840456221945JMUJMU DENTAL, INCEGZ2026-06-08
00840456222317JMUJMU DENTAL, INCEGZ2026-06-08
00840456222324JMUJMU DENTAL, INCEGZ2026-06-08
00840456222331JMUJMU DENTAL, INCEGZ2026-06-08
00840456222348JMUJMU DENTAL, INCEGZ2026-06-08
00840456222355JMUJMU DENTAL, INCEGZ2026-06-08
00840456222362JMUJMU DENTAL, INCEGZ2026-06-08
00840456221884JMUJMU DENTAL, INCEGZ2026-06-05
10371347019633Advance Dental ProductsThe Atlanta Dental Supply CompanyEGZ2025-11-18
10304040192112CarinaHENRY SCHEIN, INC.EGZ2025-05-13
08717228440007DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440014DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440021DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440113DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440120DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440137DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440144DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440168DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440175DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440182DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440212DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440250CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440281CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440298CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440366CeflaDuPhaMed B.V.EGZ2023-11-23