FDA.reportPublic FDA data

Codonics DirectVista Thermal Film, 1417-DVBT

Primary DI
10814905020677
Brand
Codonics DirectVista Thermal Film, 1417-DVBT
Company
CODONICS INC.
Model
1417-DVBT
Device description
1417-DVBT Blue Base Film (100 sheet cassette)
Published
2020-02-05
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

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
10814905020677PackageGS15In Commercial Distribution
00814905020670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081490502067710814905020677
00814905020670008149050206708149050206700814905020670

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature50 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4402431334support@codonics.com

Regulatory Flags#

DUNS number
101533727
Device count
1
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
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
00814905021400Codonics Safe Label System®(SLS) 610i Point of Care Station - 170C610i PCS2026-04-20
00814905021417Codonics Safe Label System®(SLS) 620i Point of Care Station - 170C620i PCS2026-04-20
00814905021431Codonics Safe Label System®(SLS) 630i Point of Care Station - 170C630i PCS2026-04-20
00814905021455Codonics Safe Label System®(SLS) 700i Point of Care Station - 170C700i PCS2026-04-20
00814905021479Safe Waste System Spectrophotometer for Pharmaceutical AnalysisSWS2026-04-20
00814905021103Codonics Safe Label System®(SLS) 600i Point of Care Station - 170C600i PCS2023-06-08
00814905020298Codonics Virtua® Controller - 73CVirtua - 73C2023-09-27
00814905020304Codonics Virtua® XR Controller - 74CVirtua XR - 74C2023-09-27
00814905020311Codonics Virtua® C Controller - 91CVirtua C -91C2023-09-27
00814905020328Codonics Virtua® Medical Disc PublisherVirtua2023-09-27
00814905020335Codonics Virtua® XR Medical Disc PublisherVirtua XR2023-09-27
00814905020342Codonics Virtua® C Controller - 90CVirtua C -90C2023-09-27
00814905020359Codonics Virtua® C/E Medical Disc PublisherVirtua C/E2023-09-27
00814905020380Codonics Virtua® Controller - 71CVirtua -71C2023-09-27
00814905020397Codonics Virtua® Controller - 75CVirtua -75C2023-09-27
00814905020403Codonics Virtua® XR Controller - 72CVirtua XR - 72C2023-09-27
00814905020410Codonics Virtua® XR Controller - 76CVirtua XR - 76C2023-09-27
00814905020427Codonics Virtua® C Controller - 92CVirtua C -92C2023-09-27
00814905020823Codonics Safe Label System®(SLS) 550i Point of Care Station - 144C550i PCS2018-10-05
00814905021059Codonics DirectVista Thermal Film, 810-DVC810-DVC2021-05-17

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
06430035874996Imaging 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