FDA UDI In Commercial Distribution 🇺🇸 United States

Rad-Sure™

DI: 00810106410326 · Model: 15 Gy Sample @24SH (consolidated XR/G) · ASHLAND SPECIALTY INGREDIENTS G.P.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Rad-Sure™
Primary DI
00810106410326
Version / Model
15 Gy Sample @24SH (consolidated XR/G)
Catalog Number
980690
Company Name
ASHLAND SPECIALTY INGREDIENTS G.P.
Labeler DUNS
152728887
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-04-24
Public Version
1
Public Version Date
2023-05-02
Public Version Status
New
Public Device Record Key
036c98e5-278e-4fbf-af07-00e32389e138

Device Description

Blood Irradiation Indicator

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KSS Supplies, Blood-Bank

GMDN Terms

Code Name
63406 Device operating status label/tag, single-use

Identifiers

Type ID
Primary 00810106410326