FDA.reportPublic FDA data

Cefla

Primary DI
08717228441790
Brand
Cefla
Company
DuPhaMed B.V.
Model
CEF5061
Catalog number
97901671
Device description
Clip for Phosphor Plate Holder
Published
2023-11-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
08717228440168PrimaryGS10
08717228440465PrimaryGS10
08717228441790Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717228440168087172284401688717228440168
08717228440465087172284404658717228440465
08717228441790087172284417908717228441790

GMDN Terms#

Term, Definition table
TermDefinition
Dental x-ray film holder, reusableA device designed to hold x-ray film while a dental x-ray is being taken and that enables insertion, positioning, stabilization, and removal of the x-ray film for either extraoral or intraoral dental imaging procedures. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
413491023
Device count
300
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
08717228442537Flow DentalEarflow34815002023-11-23

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