Imaging Plates

Primary DI
06430035874996
Brand
Imaging Plates
Company
PaloDEx Group Oy
Model
901244-PTU
Device description
STD IP SET S0 X 6 OPTIME TYPE
Published
2024-02-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IWZFilm, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWZFilm, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430035874996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430035874996064300358749966430035874996

GMDN Terms#

Term, Definition table
TermDefinition
Digital imaging phosphor plate, dental, intraoralA thin, photostimulable, dental device intended to be placed in an appropriate cover (not included), and subsequently introduced into the oral cavity and exposed to radiation by a diagnostic imaging x-ray system to record a radiation pattern of a patient’s teeth and/or jaws. Following exposure, it is transferred, typically in a light-shielding container (not included), to a computed radiography scanner (CR) to produce a digital image of the latent image formed on the plate. This is a reusable device.

Regulatory Flags#

DUNS number
459955188
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
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
06430035874637Imaging Plates901256-PTU2024-02-22
06430035874644Imaging Plates901257-PTU2024-02-22
06430035874651Imaging Plates901258-PTU2024-02-22
06430035874668Imaging Plates901259-PTU2024-02-22
06430035874675Imaging Plates901248-PTU2024-02-22
06430035874682Imaging Plates901249-PTU2024-02-22
06430035874699Imaging Plates901250-PTU2024-02-22
06430035874705Imaging Plates901251-PTU2024-02-22
06430035875009Imaging Plates901245-PTU2024-02-22
06430035875016Imaging Plates901246-PTU2024-02-22
06430035875023Imaging Plates901247-PTU2024-02-22
06430035875030Imaging Plates901252-PTU2024-02-22
06430035875047Imaging Plates901253-PTU2024-02-22
06430035875054Imaging Plates901254-PTU2024-02-22
06430035875061Imaging Plates901255-PTU2024-02-22
06430035873357COMFORT OCCLUSAL 4C ACCESSORY KIT900320-PTU900320-PTU2025-12-23
06430035873388OCCLUSAL 4C REFILL KIT900802-DEX2025-12-23
06430035875191ORTHOPANTOMOGRAPH™ OP 3DPCX-1901308-PTU2025-07-15
06430035875184ORTHOPANTOMOGRAPH™ OP 3DPCX-1901307-PTU2025-03-11
06430035875177ORTHOPANTOMOGRAPH™ OP 3DPCX-1901301-PTU2024-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810050855843Rad ControlTYPENEX MEDICAL LLCIWZ2026-05-06
06430035874637Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035874644Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035874651Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035874668Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035874675Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035874682Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035874699Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035874705Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035875009Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035875016Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035875023Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035875030Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035875047Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035875054Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035875061Imaging PlatesPaloDEx Group OyIWZ2024-02-22
40889971051260D-SpeedCARESTREAM HEALTH, INC.IWZ2022-01-11
40889971463117Medical X-ray Green / MXG FilmCARESTREAM HEALTH, INC.IWZ2021-05-30
H65811253101Henry ScheinHENRY SCHEIN, INC.IWZ2020-06-18
H65811253331Henry ScheinHENRY SCHEIN, INC.IWZ2020-06-18
H65890042830Henry ScheinHENRY SCHEIN, INC.IWZ2020-06-09
H65890042840Henry ScheinHENRY SCHEIN, INC.IWZ2020-06-09
H65890042850Henry ScheinHENRY SCHEIN, INC.IWZ2020-06-09
H65890042860Henry ScheinHENRY SCHEIN, INC.IWZ2020-06-09
H65890042870Henry ScheinHENRY SCHEIN, INC.IWZ2020-06-09
H65890042880Henry ScheinHENRY SCHEIN, INC.IWZ2020-06-09
H65890042890Henry ScheinHENRY SCHEIN, INC.IWZ2020-06-09
H65810012430Henry ScheinHENRY SCHEIN, INC.IWZ2020-05-14
H65810058710Henry ScheinHENRY SCHEIN, INC.IWZ2020-05-14
H65810061070Henry ScheinHENRY SCHEIN, INC.IWZ2020-05-14