FDA.reportPublic FDA data

Gafchromic™

Primary DI
00810106410364
Brand
Gafchromic™
Company
ASHLAND SPECIALTY INGREDIENTS G.P.
Model
QuiCk Phantom w/EBT4P
Catalog number
980955
Published
2023-04-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
IXGPhantom, Anthropomorphic, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXGPhantom, Anthropomorphic, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810106410364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810106410364008101064103648101064103640810106410364

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality therapeutic radiation phantom, test objectA device consisting of a variety of multi-modality radiation therapy phantom designs. It can consist of an object of uniform material density or a two or three-dimensional (3-D) model containing patterns of objects, materials, or openings. It is available in both fixed and variable configurations including holders for ionization chambers, dosimeters or other radiation measurement instruments. It is a quality assurance (QA) device used in the calibration of photon and electron beam emitting radiation therapy systems and the measurement of performance attributes, e.g., beam flatness, symmetry, dose depth or geometric accuracy.

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
00812266030932Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030949Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030956Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030963Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030970Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030987Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030994Rando®Providus Holdings, Inc.IXG2024-07-11
00812266031007Rando®Providus Holdings, Inc.IXG2024-07-11
06977071930908MeicenGuangdong Meicen Medical Equipment Co., Ltd.IXG2024-06-21
00812266030758LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030765LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030772LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030789LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030796LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030802LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030697LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
00812266030703LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
00812266030710LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
00812266030727LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
00812266030734LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
00812266030741LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
09355529000033T1CMR Phantom (1.5T)RESONANCE HEALTH ANALYSIS SERVICES PTY LTDIXG2024-04-17
09355529000064T1CMR Phantom (3.0T)RESONANCE HEALTH ANALYSIS SERVICES PTY LTDIXG2024-04-17
09355529000071T2CMR PhantomRESONANCE HEALTH ANALYSIS SERVICES PTY LTDIXG2024-04-17
09355529000088R2*/T2* PhantomRESONANCE HEALTH ANALYSIS SERVICES PTY LTDIXG2024-04-17
00812266030673LiquiPhil™Providus Holdings, Inc.IXG2024-03-18
00812266030680LiquiPhil™Providus Holdings, Inc.IXG2024-03-18
EIBASR020010myQA® SRS Phantom CyberknifeIBA Dosimetry GmbHIXG2023-10-10
00850019946505Standard Imaging Lucy 3D QA PhantomSTANDARD IMAGING INC.IXG2023-06-22
00850019946512Standard Imaging MIMI PhantomSTANDARD IMAGING INC.IXG2023-06-22