Gammacell

GUDID 00754014600014

Blood Irradiator

Best Theratronics Ltd

Ionizing-radiation blood irradiator

• Primary Device ID: 00754014600014
• NIH Device Record Key: 967042ad-577e-43d4-9be0-59685250b2be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gammacell
• Version Model Number: 1000
• Company DUNS: 243606832
• Company Name: Best Theratronics Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does n
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6135912100
• Email: compliance@theratronics.ca
• Phone: 6135912100
• Email: compliance@theratronics.ca

Device Identifiers

Device Issuing Agency	Device ID
GS1	00754014600014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050963

FDA Product Code

• MOT: Irradiator, Blood To Prevent Graft Versus Host Disease

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Gammacell]

• 00754014600021: Blood Irradiator
• 00754014600014: Blood Irradiator
• 07540146000029: Blood Irradiator
• 07540146000012: Blood Irradiator