VariStrand with I-Seed

GUDID 00813787021171

VariStrand with x = 1-12 seeds and 0 or more spacers

THERAGENICS CORPORATION

Manual brachytherapy source, permanent implant

• Primary Device ID: 00813787021171
• NIH Device Record Key: 3af77599-60ae-4a5e-bba1-c09d1793ac77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VariStrand with I-Seed
• Version Model Number: XX772xi
• 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	00813787021171 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023179

FDA Product Code

• KXK: Source, Brachytherapy, Radionuclide

Sterilization

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

[00813787021171]

Ethylene Oxide

[00813787021171]

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: 2016-02-02

Devices Manufactured by THERAGENICS CORPORATION

• 00813787022253 - TheraMark™: 2022-06-02 TheraMark (AgX100 loose seed -12 cm ) - STERILE
• 00813787022260 - TheraMark™: 2022-06-02 TheraMark (TheraStrand with AgX100 -12 cm) - STERILE
• 00813787022277 - TheraMark™: 2022-06-02 TheraMark (TheraStrand with AgX100 -12 cm) - STERILE
• 00813787022284 - TheraMark™: 2022-06-02 TheraMark (AgX100 loose seed - 7 cm ) - STERILE
• 00813787022291 - TheraMark™: 2022-06-02 TheraMark (AgX100 loose seed - 5 cm ) - STERILE
• 00813787022307 - TheraMark™: 2022-06-02 TheraMark (TheraStrand with AgX100 - 7 cm) - STERILE
• 00813787022314 - TheraMark™: 2022-06-02 TheraMark (TheraStrand with AgX100 - 5 cm) - STERILE
• 00813787022321 - TheraMark™: 2022-06-02 TheraMark (Anchorseed with AgX100 - 7 cm) -STERILE