TheraStrand® with I-Seed

GUDID 00813787020310

TheraStrand® TSL in TPSII Ind.– 15 stranded seeds per mag- STERILE

THERAGENICS CORPORATION

Manual brachytherapy source, permanent implant

• Primary Device ID: 00813787020310
• NIH Device Record Key: 5c714ca3-6224-4b34-9ba4-c10fbfa01152
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TheraStrand® with I-Seed
• Version Model Number: XX7215iN
• 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	00813787020310 [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

[00813787020310]

Ethylene Oxide

[00813787020310]

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 [TheraStrand® with I-Seed]

• 00813787020464: TheraStrand with x = 1-12 seeds and 0 or more spacers for CN
• 00813787020457: Loose TheraStrand® with 1-6 seeds, standard spacing, in TPSII Ind. for CN
• 00813787020440: Loose TheraStrand® with 1-6 seeds, standard spacing for CN
• 00813787020389: TheraStrand with 10 seeds and 0 or spacers in Mesh
• 00813787020372: TheraStrand® with x = 1-12 seeds and 0 or more spacers
• 00813787020365: Loose TheraStrand® with 1-6 seeds, standard spacing, in TPSII Ind.
• 00813787020358: Loose TheraStrand® with 1-6 seeds, standard spacing
• 00813787020327: TheraStrand® TSL in Flatpack – 15 stranded seeds per mag- STERILE
• 00813787020310: TheraStrand® TSL in TPSII Ind.– 15 stranded seeds per mag- STERILE
• 00813787020303: TheraStrand® TSL in TPSII Single – 15 stranded seeds per mag- STERILE