TheraStrand® with TheraSeed®

GUDID 00813787020785

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

THERAGENICS CORPORATION

Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant

• Primary Device ID: 00813787020785
• NIH Device Record Key: dfff59e2-cccf-4a95-bf8a-bb9d67309062
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TheraStrand® with TheraSeed®
• Version Model Number: XX7215N
• 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	00813787020785 [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

[00813787020785]

Ethylene Oxide

[00813787020785]

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 TheraSeed®]

• 00813787020938: TheraStrand with x = 1-12 seeds and 0 or more spacers for CN
• 00813787020921: Loose TheraStrand with 1-6 seeds, standard spacing, in TPSII Ind. for CN
• 00813787020914: Loose TheraStrand with 1-6 seeds, standard spacing for CN
• 00813787020853: TheraStrand with 10 seeds and 0 or spacers in Mesh
• 00813787020846: TheraStrand with x = 1-12 seeds and 0 or more spacers
• 00813787020839: Loose TheraStrand with 1-6 seeds, standard spacing, in TPSII Ind.
• 00813787020822: Loose TheraStrand with 1-6 seeds, standard spacing
• 00813787020792: TheraStrand TSL in Flatpack – 15 stranded seeds per mag- STERILE
• 00813787020785: TheraStrand TSL in TPSII Ind.– 15 stranded seeds per mag- STERILE
• 00813787020778: TheraStrand TSL in TPSII Single – 15 stranded seeds per mag- STERILE