FDA.reportPublic FDA data

Rad-Sure™

Primary DI
00810106410333
Brand
Rad-Sure™
Company
ASHLAND SPECIALTY INGREDIENTS G.P.
Model
25 Gy Sample @24SH (consolidated XR/G)
Catalog number
980675
Device description
Blood Irradiation Indicator
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
KSSSupplies, Blood-Bank

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSSSupplies, Blood-BankHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810106410333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810106410333008101064103338101064103330810106410333

GMDN Terms#

Term, Definition table
TermDefinition
Device operating status label/tag, single-useA label or a tag intended to indicate/collect the operating status of a device to which it is attached; it does not include any additional functionality and does not include a sterilization process indicator. It is typically constructed from a durable material and may be designed as a locking tag. This is a single-use device.

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
07540151300121RadTagRadtag Technologies IncKSS2025-12-30
07540151300138RadTagRadtag Technologies IncKSS2025-12-30
07540151300145RadTagRadtag Technologies IncKSS2025-12-30
07540151300152RadTagRadtag Technologies IncKSS2025-12-30
05060242472596ORTHO® Elution KitALBA BIOSCIENCE LIMITEDKSS2025-12-04
09555240405616SampLok® Sampling Kit 16mLITL ASIA PACIFIC SDN. BHD.KSS2025-06-04
19555240405613SampLok® Sampling Kit 16mLITL ASIA PACIFIC SDN. BHD.KSS2025-06-04
07540151300107AccuTagRadtag Technologies IncKSS2023-11-02
05060242477959ALBA Elution KitALBA BIOSCIENCE LIMITEDKSS2023-10-13
00810106410340Rad-Sure™ASHLAND SPECIALTY INGREDIENTS G.P.KSS2023-05-10
00810106410326Rad-Sure™ASHLAND SPECIALTY INGREDIENTS G.P.KSS2023-04-24
07540151300046RadTagRadtag Technologies IncKSS2022-12-02
07540151300053RadTagRadtag Technologies IncKSS2022-12-02
07540151300060RadTagRadtag Technologies IncKSS2022-12-02
07540151300077RadTagRadtag Technologies IncKSS2022-12-02
07540151300008RadTagRadtag Technologies IncKSS2022-12-01
07540151300015RadTagRadtag Technologies IncKSS2022-12-01
07540151300022RadTagRadtag Technologies IncKSS2022-12-01
07540151300039RadTagRadtag Technologies IncKSS2022-12-01
10812269031230Typesafe 2.0TYPENEX MEDICAL LLCKSS2022-11-21
10812269031254Typesafe 2.0TYPENEX MEDICAL LLCKSS2022-11-21
10812269031278TypesafeTYPENEX MEDICAL LLCKSS2022-11-21
10812269031285TypesafeTYPENEX MEDICAL LLCKSS2022-11-21
00812269031240Typesafe 2.0TYPENEX MEDICAL LLCKSS2022-11-21
00812269031264Typesafe 2.0TYPENEX MEDICAL LLCKSS2022-11-21
20812269031275TypesafeTYPENEX MEDICAL LLCKSS2022-11-21
00812269031295TypesafeTYPENEX MEDICAL LLCKSS2022-11-21
10810020440536Hematype Segment DeviceFresenius Kabi AGKSS2022-11-08
20810020440533Hematype Segment DeviceFresenius Kabi AGKSS2022-11-08
04086000860161CompoMat G5 PlusFresenius Kabi AGKSS2022-11-07