Rad Control

Basic Information

• Brand Name: Rad Control
• Primary DI: 00892159002178
• Version / Model: RT0202
• Company Name: TYPENEX MEDICAL LLC
• Labeler DUNS: 600850213
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2022-11-23
• Public Version: 1
• Public Version Date: 2022-12-01
• Public Version Status: New
• Public Device Record Key: a6a1dbfc-31da-47de-8ff1-21d5b9ad99c1

Device Description

15 Gy Irradiation Indicator Tag - X Ray

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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IWZ	Film, Radiographic	Radiology	892.1840	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64745	Blood irradiation indicator	A label-like device intended to be attached to a blood bag prior to ionizing-radiation (e.g., gamma, X-ray) blood irradiation to verify the type and broad dosage of radiation delivered to the blood. Blood irradiation is a technique designed to inactivate donor lymphocytes and help prevent transfusion-associated graft-versus-host disease. The label is specific to a type of radiation and typically includes a permanent colour-change indicator for dosage, and areas for recording other related data. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00892159002178	GS1
Unit of Use	00810050855136	GS1