AnchorSeed with I-Seed

GUDID 00813787021133

AnchorSeed in Flatpack – 15 stranded seeds per mag- STERILE

THERAGENICS CORPORATION

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

• Primary Device ID: 00813787021133
• NIH Device Record Key: 4af301b5-60d5-4ca9-825c-9333d5f16174
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AnchorSeed with I-Seed
• Version Model Number: XX77215iF
• 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	00813787021133 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083274

FDA Product Code

• KXK: Source, Brachytherapy, Radionuclide

Sterilization

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

[00813787021133]

Ethylene Oxide

[00813787021133]

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: 2016-01-20

On-Brand Devices [AnchorSeed with I-Seed]

• 00813787021331: AnchorSeed/TSL in FlatPack – 15 stranded seeds per mag– STERILE
• 00813787021324: AnchorSeed/TSL in TPSII Ind.– 15 stranded seeds per mag- STERILE
• 00813787021133: AnchorSeed in Flatpack – 15 stranded seeds per mag- STERILE
• 00813787021119: AnchorSeed in TPSII Ind.– 15 stranded seeds per mag- STERILE