TheraLoad® with TheraSeed®

GUDID 00813787020945

TheraLoad with x = 1-20 seeds and 0 or more spacers for CN

THERAGENICS CORPORATION

Manual brachytherapy source, permanent implant

• Primary Device ID: 00813787020945
• NIH Device Record Key: d6c8f6f4-81af-4870-8b9a-31c803c80996
• Commercial Distribution Discontinuation: 2016-10-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: TheraLoad® with TheraSeed®
• Version Model Number: XX82x
• Company DUNS: 114379522
• Company Name: THERAGENICS CORPORATION
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813787020945 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043596

FDA Product Code

• KXK: Source, Brachytherapy, Radionuclide

Sterilization

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

[00813787020945]

Radiation Sterilization

[00813787020945]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-21

On-Brand Devices [TheraLoad® with TheraSeed® ]

• 00813787020945: TheraLoad with x = 1-20 seeds and 0 or more spacers for CN
• 00813787020860: TheraLoad® with x = 1-20 seeds and 0 or more spacers