DRYSTAR DT 2 MAMMO

Primary DI
05414904042830
Brand
DRYSTAR DT 2 MAMMO
Company
AGFA
Model
DRYSTAR DT 2 MAMMO 25X30
Catalog number
ERE6E
Published
2022-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
05414904042830PackageGS15In Commercial Distribution
05414904015483PrimaryGS10
05414904041970Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414904042830054149040428305414904042830
05414904015483054149040154835414904015483
05414904041970054149040419705414904041970

GMDN Terms#

Term, Definition table
TermDefinition
Medical printer filmA thin transparent film intended to be used with an appropriate printer to produce a hard copy of a medical image generated by a digital diagnostic radiological system [during, e.g., angiography, magnetic resonance imaging (MRI), nuclear medicine, ultrasound (US), computed tomography (CT)]; it is not photographically light sensitive. It is intended to assist high-quality diagnostic evaluation and is used as a hard-copy alternative to, e.g., medical printer paper or photographically sensitive x-ray film. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25Centimeter
Width30Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature4 Degrees Celsius25 Degrees Celsius
Special Storage Condition, Specify00Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)777-2432salesinfo@agfa.com

Regulatory Flags#

DUNS number
374444883
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
05414904027158CR MD4.0 GENERAL PLATECR MD4.0 GENERAL PLATE 10X12EJY1G2016-09-01
05414904027202CR MD4.0 GENERAL PLATECR MD4.0 GENERAL PLATE 35X43EJYU32016-09-01
05414904027219CR MD4.0 GENERAL PLATECR MD4.0 GENERAL PLATE 35X35EJYV52016-09-01
05414904027226CR MD4.0 GENERAL PLATECR MD4.0 GENERAL PLATE 24X30EJYW72016-09-01
05414904027363CR MD4.0 GENERAL PLATECR MD4.0 GENERAL PLATE 18X24EJYXA2016-09-01
05414904027509CR MD4.0 GENERAL PLATECR MD4.0 GENERAL PLATE 15X30EJYYC2016-09-01
05414904027516CR MD4.0 GENERAL PLATECR MD4.0 GENERAL PLATE 8X10EJYZE2016-09-01
05414904027943CR MD4.0T PLATECR MD4.0T PLATE 35X43E4UWL2016-09-01
05414904027967CR MD4.0T PLATECR MD4.0T PLATE 24X30E4UZR2016-09-01
05414904027998CR MD4.0T PLATECR MD4.0T PLATE 18X24E4VCK2016-09-01
05414904028001CR MD4.0T PLATECR MD4.0T PLATE 15X30E4VEO2016-09-01
05414904043257CR MD4.0R GENERAL PLATECR MD4.0R GENERAL PLATE 15X30E5PU32016-09-01
05414904043264CR MD4.0R GENERAL PLATECR MD4.0R GENERAL PLATE 18X24E5PT12016-09-01
05414904043271CR MD4.0R GENERAL PLATECR MD4.0R GENERAL PLATE 24X30E5PSY2016-09-01
05414904043288CR MD4.0R GENERAL PLATECR MD4.0R GENERAL PLATE 35X35E5PRW2016-09-01
05414904043295CR MD4.0R GENERAL PLATECR MD4.0R GENERAL PLATE 35X43E5PNO2016-09-01
05414904043301CR MD4.0R GENERAL SR PLATECR MD4.0R GENERAL SR PLATE 35X35E5POQ2016-09-01
05414904043318CR MD4.0R GENERAL SR PLATECR MD4.0R GENERAL SR PLATE 35X43E5PMM2016-09-01
05414904044100CR MD4.0 GENERAL PLATECR MD4.0 GENERAL PLATE 14X515O6MS2016-09-01
05414904092538CR MD1.0 GENERAL PLATECR MD1.0 GENERAL PLATE 35X435R3HW2016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810050855843Rad ControlTYPENEX MEDICAL LLCIWZ2026-05-06
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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
06430035874996Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035875009Imaging PlatesPaloDEx Group OyIWZ2024-02-22
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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
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H65811253101Henry ScheinHENRY SCHEIN, INC.IWZ2020-06-18
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H65810012430Henry ScheinHENRY SCHEIN, INC.IWZ2020-05-14
H65810058710Henry ScheinHENRY SCHEIN, INC.IWZ2020-05-14