I-Seed Agx100

GUDID 00813787020266

C20 IsoLoader magazines in TPSII Ind. – 20 seeds per mag- STERILE

THERAGENICS CORPORATION

Manual brachytherapy source, permanent implant

• Primary Device ID: 00813787020266
• NIH Device Record Key: 7cb123a5-b861-4c36-b533-eeafe8743940
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: I-Seed Agx100
• Version Model Number: XX5057iN
• 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	00813787020266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103319

FDA Product Code

• KXK: Source, Brachytherapy, Radionuclide

Sterilization

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

[00813787020266]

Moist Heat or Steam Sterilization

[00813787020266]

Moist Heat or Steam Sterilization

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 [I-Seed Agx100]

• 00813787020341: Notched Seed Carrier where “mm” = 10, 12, 14, 16, 18, 20, or 22mm
• 00813787020334: Circular Seed Carrier where “mm” = 10, 12, 14, 16, 18, 20, or 22mm
• 00813787020297: Seeds for IsoStrand - STERILE
• 00813787020280: Seeds for IsoCartridge - STERILE
• 00813787020273: C20 in TPSII Single x = 10, 15 or 20 seeds per mag - STERILE
• 00813787020266: C20 IsoLoader magazines in TPSII Ind. – 20 seeds per mag- STERILE
• 00813787020259: IsoLoader magazines in TPSII Ind. - 20 seeds per mag- STERILE
• 00813787020242: C20 IsoLoader magazines in TPSII – 20 seeds per mag- STERILE
• 00813787020235: IsoLoader magazines in TPSII - 20 seeds per mag- STERILE
• 00813787020228: C20 IsoLoader magazines in TPSII – 20 seeds per mag
• 00813787020211: IsoLoader magazines in TPSII - 20 seeds per mag
• 00813787020204: In-STANT magazines in TPSII Ind. - 20 seeds per mag - STERILE
• 00813787020198: In-STANT magazines in TPSII - 20 seeds per mag - STERILE
• 00813787020181: In-STANT magazines in TPSII - 20 seeds per mag
• 00813787020174: C20 in TPSII Ind. x = 10, 15 or 20 seeds per mag - STERILE
• 00813787020167: C20 in TPSII x = 10, 15 or 20 seeds per mag - STERILE
• 00813787020150: C20 in TPSII x = 10, 15 or 20 seeds per mag
• 00813787020143: C20 in FlatPack x = (1)10, (3)15 or (7)20 seeds per mag - STERILE
• 00813787020136: C20 in FlatPack x = (1)10, (3)15 or (7)20 seeds per mag
• 00813787020129: VSM in TPSII Ind. x = 10, 15 or 20 seeds per mag - STERILE
• 00813787020112: VSM in TPSII x = 10, 15 or 20 seeds per mag - STERILE
• 00813787020105: VSM in TPSII x = 10, 15 or 20 seeds per mag
• 00813787020099: Mick magazines in TPSII Ind. x = (8)15, or (9)10 seeds per mag - STERILE
• 00813787020082: Mick magazines in TPS x = (8)15, or (9)10 seeds per mag - STERILE
• 00813787020075: Mick magazines in TPS x = (8)15, or (9)10 seeds per mag
• 00813787020068: High activity loose seeds for the Eye – STERILE
• 00813787020051: High activity loose seeds for the Eye
• 00813787020044: Loose seeds in a vial for 3rd party processing
• 00813787020037: Loose seeds in a vial - STERILE
• 00813787020020: Loose seeds in a vial