Quala

Primary DI
D02318201QU1
Brand
Quala
Company
NATIONAL DISTRIBUTION & CONTRACTING, INC.
Model
18201-QU
Catalog number
18201-QU
Device description
Quala Intraoral X-ray Film QD57 Adult D Speed DBL
Published
2017-04-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
D02318201QU31PackageHIBCC50In Commercial Distribution
D02318201QU1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental x-ray film, non-screenA non-screen x-ray film specifically sized and designed for use with dental x-ray systems. It is designed for direct exposure to x-rays and is relatively insensitive to the visible light emitted from screens. It is prepared as an emulsion of light and x-ray sensitive granules on one (single-emulsion film) or both (double-emulsion film) sides of a transparent film base made of cellulose acetate, polyester resin or other appropriate material.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius21 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
6153663230compliance@ndc-inc.com

Regulatory Flags#

DUNS number
009831413
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M220P3010088Pro AdvantageP301008P3010082017-02-13
M220P3011058Pro AdvantageP301105P3011052017-02-13
M220P3011158Pro AdvantageP301115P3011152017-02-13
D023Q4000418QualaQ40004Q400042017-02-13
D023Q400042ML1QualaQ400042MLQ400042ML2017-04-25
D023Q400122ML19QualaQ400122MLQ400122ML2017-10-18
D023Q4003017QualaQ40030Q400302017-02-13
D23Q4001217QualaQ40012Q400122017-02-13
M2207250003Pro Advantage72000720002025-09-11
M220761002Pro Advantage76100761002025-09-11
M220762002Pro Advantage76200762002025-09-11
M220767000Pro Advantage76700767002025-09-11
M220768001Pro Advantage76800768002025-09-11
M220768011Pro Advantage76801768012025-09-11
M220769000Pro Advantage76900769002025-09-11
M220770001Pro Advantage77000770002025-09-11
M220771001Pro Advantage77100771002025-09-11
M220720005Pro Advantage72000720002025-09-11
M220761003Pro Advantage76100761002025-09-11
M220762003Pro Advantage76200762002025-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810050855843Rad ControlTYPENEX MEDICAL LLCIWZ2026-05-06
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
10304040040895Henry ScheinHENRY SCHEIN, INC.IWZ2019-04-03
10304040040918Henry ScheinHENRY SCHEIN, INC.IWZ2019-04-03
10304040040925Henry ScheinHENRY SCHEIN, INC.IWZ2019-04-03
10304040040932Henry ScheinHENRY SCHEIN, INC.IWZ2019-04-03
10304040040949Henry ScheinHENRY SCHEIN, INC.IWZ2019-04-03
10304040040956Henry ScheinHENRY SCHEIN, INC.IWZ2019-04-03
10304040040963Henry ScheinHENRY SCHEIN, INC.IWZ2019-04-03
10304040040970Henry ScheinHENRY SCHEIN, INC.IWZ2019-04-03
10304040040987Henry ScheinHENRY SCHEIN, INC.IWZ2019-04-03
10304040041007Henry ScheinHENRY SCHEIN, INC.IWZ2019-04-03
10304040041014Henry ScheinHENRY SCHEIN, INC.IWZ2019-04-03
10304040041021Henry ScheinHENRY SCHEIN, INC.IWZ2019-04-03
40889971069593DRYVIEW DVB+ Laser Imaging FilmCARESTREAM HEALTH, INC.IWZ2017-12-22
40889971858678DRYVIEW DVB+ Laser Imaging FilmCARESTREAM HEALTH, INC.IWZ2017-12-22
40889971575490DRYVIEW DVB+ Laser Imaging FilmCARESTREAM HEALTH, INC.IWZ2017-12-21