FDA.reportPublic FDA data

dose-map™

Primary DI
00810106410449
Brand
dose-map™
Company
ASHLAND SPECIALTY INGREDIENTS G.P.
Model
Gammacell-3000 Short
Catalog number
827360
Device description
blood irradiator dosimetry system
Published
2023-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
IXACassette, Radiographic Film

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXACassette, Radiographic FilmRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810106410449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810106410449008101064104498101064104490810106410449

GMDN Terms#

Term, Definition table
TermDefinition
X-ray film cassette holderA device designed to position and hold the cassettes containing x-ray film during medical or dental imaging or radiation therapy procedures. It is used in conjunction with multiformat cameras and diagnostic imaging and radiation therapy modalities, e.g., nuclear medicine systems, ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
152728887
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
00810106410951Gafchromic™EBT4 1.3x2 @300SH9933212026-04-14
00810106411279Gafchromic™EBT-4 ZAP CAL STRIP @12SH 9951202026-03-26
00810106411040Gafchromic™EBT-4 CIRS STEEV @ 20SH 9951192026-03-02
00810106411057Gafchromic™EBT-4 ZAP CAL STRIP @12SH 9952102026-03-02
00810106411064Gafchromic™EBT-XD RBY @ 50SH9949582026-03-02
00810106411071Gafchromic™EBT-4 35MM @ 100SH9950532026-03-02
00810106411088Gafchromic™EBT-4 18 MM @ 100SH9950522026-03-02
00810106411095Gafchromic™MD-V3 1.3X2 @200SH9933002026-03-02
00810106411101Gafchromic™HD-V2 1.3x2 @50SH9933172026-03-02
00810106411118Gafchromic™1.3X2 @300SH9933212026-03-02
00810106410807Gafchromic™Pnt-Dos™ Device9879612025-02-13
00810106410845FilmQA Pro8.09879572025-02-12
00810106410937Gafchromic™ThorX Rod Film @59904412025-01-28
00810106410944Gafchromic™ThorX Spine Film Insert @59904422025-01-28
00810106410920Gafchromic™EBT4-XD Lucy-EA Multi @69893962024-12-30
00810106410883Gafchromic™EBT4 Lucy-EA Multi @69893962024-10-25
00810106410913Gafchromic™EBT4 Disc Gyro @209894052024-11-21
00810106410906Gafchromic™HD-V2 IO 22685-2 @ 50SH9894112024-11-11
00810106410869Gafchromic™EBT-XD Lucy Ortho @19893942024-10-25
00810106410876Gafchromic™EBT4 Lucy-EA Cal Strip9893952024-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850077007293Huestis Medical Flexi-HolderHUESTIS MACHINE CORPORATIONIXA2025-03-05
05055449402958KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXA2023-07-11
05055449413992KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXA2023-07-11
05055449415927KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXA2023-07-11
05055449415989KENEXKENEX (ELECTRO-MEDICAL) LIMITEDIXA2023-07-11
00810106410432dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410456dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410463dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410470dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410487dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410494dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410500dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410517dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410524dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410531dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410548dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410555dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410562dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410579dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-10
00810106410418dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-04
00810106410425dose-map™ASHLAND SPECIALTY INGREDIENTS G.P.IXA2023-05-04
60889971033574DIRECTVIEW CR Long-Length Cassette with PQ ScreenCARESTREAM HEALTH, INC.IXA2021-06-06
00810050241236N/ADOMICO MED-DEVICE, LLCIXA2020-09-24
00810050240994NADOMICO MED-DEVICE, LLCIXA2020-09-24
60889978607334MIN-R 2 Cassette with MIN-R 2190 ScreenCARESTREAM HEALTH, INC.IXA2017-11-07
08809413810198Radiographic Film CassetteJPI HEALTHCARE. CO., LTD.IXA2017-08-01
08809413810228Radiographic Film CassetteJPI HEALTHCARE. CO., LTD.IXA2017-08-01
08809413810235Radiographic Film CassetteJPI HEALTHCARE. CO., LTD.IXA2017-08-01
08809413810242Radiographic Film CassetteJPI HEALTHCARE. CO., LTD.IXA2017-08-01
08809413810259Radiographic Film CassetteJPI HEALTHCARE. CO., LTD.IXA2017-08-01