Gammacell

Basic Information

• Brand Name: Gammacell
• Primary DI: 07540146000029
• Version / Model: 3000
• Company Name: Best Theratronics Ltd
• Labeler DUNS: 243606832
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2023-08-03
• Public Version Status: Update
• Public Device Record Key: 6b86bccf-ee55-41c9-a63b-b7c291311d26

Device Description

Blood Irradiator

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
MOT	Irradiator, Blood To Prevent Graft Versus Host Disease	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
17437	In vitro ionizing-radiation blood irradiator	An electrically-powered device assembly designed for the in vitro irradiation of blood and/or blood components with ionizing radiation (e.g., gamma), typically used to treat cancer patients by inactivating lymphocytes and for the prevention of transfusion-associated graft-versus-host diseases. It operates off-line (i.e. the blood is not returned to the patient in a closed circuit) and typically includes a shielded, double encapsulated, long half-life radiation source (e.g., Cesium 137), blood/blood product containers, safety interlocks, a timing mechanism, and a means of retrieving samples.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540146000029	GS1

Premarket Submissions

Submission Number	Supplement Number
K050963	000