TheraSleeve® with I-Seed

GUDID 00813787020419

TheraSleeve with x = 1-20 seeds and 0 or more spacers

THERAGENICS CORPORATION

Manual brachytherapy source, permanent implant

• Primary Device ID: 00813787020419
• NIH Device Record Key: 53aa2b48-24ac-422d-9be5-1390f6154332
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TheraSleeve® with I-Seed
• Version Model Number: XX92xi
• 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	00813787020419 [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

[00813787020419]

Ethylene Oxide

[00813787020419]

Ethylene Oxide

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 [TheraSleeve® with I-Seed]

• 00813787020495: TheraSleeve with x = 1-20 seeds and 0 or more spacers for CN
• 00813787020433: TheraSleeve with x = 1-12 seeds and 0 or more markers
• 00813787020419: TheraSleeve with x = 1-20 seeds and 0 or more spacers