FDA.report

Gafchromic™

Primary DI
00850000065352
Brand
Gafchromic™
Company
ASHLAND SPECIALTY INGREDIENTS G.P.
Model
XR-RV3 Comparator Strip
Catalog number
828231
Published
2022-09-06
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

Related Records

Product Codes

CodeName
IWZFilm, Radiographic

Product Code Classifications

CodeDeviceSpecialtyClass
IWZFilm, RadiographicRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850000065352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000065352008500000653528500000653520850000065352

GMDN Terms

TermDefinition
Medical x-ray film, non-screenA non-screen x-ray film specifically designed for use in medical imaging applications. Non-screen x-ray film 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
152728887
Device count
1
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

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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
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00810106410944Gafchromic™ThorX Spine Film Insert @59904422025-01-28
00810106410920Gafchromic™EBT4-XD Lucy-EA Multi @69893962024-12-30
00810106410913Gafchromic™EBT4 Disc Gyro @209894052024-11-21
00810106410906Gafchromic™HD-V2 IO 22685-2 @ 50SH9894112024-11-11
00810106410869Gafchromic™EBT-XD Lucy Ortho @19893942024-10-25
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00810106410883Gafchromic™EBT4 Lucy-EA Multi @69893962024-10-25
00810106410890Gafchromic™EBT-XD IO 22685-1 @ 50SH9894122024-10-25
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Primary DIBrandCompanyProduct codePublished
00810106411040Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2026-03-02
00810106411057Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2026-03-02
00810106411064Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2026-03-02
00810106411071Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2026-03-02
00810106411088Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2026-03-02
00810106411095Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2026-03-02
00810106411101Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2026-03-02
00810106411118Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2026-03-02
D678734701Plate Transfer BoxAIR TECHNIQUES, INC.IWZ2025-09-05
00810050855457Rad ControlTYPENEX MEDICAL LLCIWZ2025-05-23
00810050855471Rad ControlTYPENEX MEDICAL LLCIWZ2025-05-23
00810106410937Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2025-01-28
00810106410944Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2025-01-28
00810106410920Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-12-30
00810106410913Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-11-21
00810106410906Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-11-11
05060608881512Precision Cut GafChromic™ FilmSUN NUCLEAR CORP.IWZ2024-11-01
00810106410869Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-10-25
00810106410876Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-10-25
00810106410883Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-10-25
00810106410890Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-10-25
00810106410852Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-10-22
00810106410814Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-09-04
00810106410821Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-09-04
00810106410838Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-09-04
00810050855648Rad ControlTYPENEX MEDICAL LLCIWZ2024-07-15
00810106410791Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-06-04
00810106410760Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-05-17
00810106410777Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.IWZ2024-05-17
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