TheraSeed

GUDID 00813787020754

Seeds for IsoCartridge - STERILE

THERAGENICS CORPORATION

Manual brachytherapy source, permanent implant

• Primary Device ID: 00813787020754
• NIH Device Record Key: 3f78868b-6814-4874-bef2-6bfeb3b4580d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TheraSeed
• Version Model Number: XX1525
• 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	00813787020754 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011493

FDA Product Code

• KPT: Calibrator, Dose, Radionuclide

Sterilization

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

[00813787020754]

Ethylene Oxide

[00813787020754]

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 [TheraSeed]

• 00813787020815: Notched Seed Carrier where “mm” = 10, 12, 14, 16, 18, 20, or 22mm
• 00813787020808: Circular Seed Carrier where “mm” = 10, 12, 14, 16, 18, 20, or 22mm
• 00813787020761: Seeds for IsoStrand - STERILE
• 00813787020754: Seeds for IsoCartridge - STERILE
• 00813787020747: Loaded C20 in TPSII Single x = 10, 15 or 20 seeds per mag - STERILE
• 00813787020730: C20 in FlatPack x = (1)10, (3)15 or (7)20 seeds per mag - STERILE
• 00813787020723: C20 IsoLoader magazines in TPSII Ind. – 20 seeds per mag- STERILE
• 00813787020716: IsoLoader magazines in TPSII Ind. - 20 seeds per mag- STERILE
• 00813787020709: C20 IsoLoader magazines in TPSII – 20 seeds per mag- STERILE
• 00813787020693: IsoLoader magazines in TPSII - 20 seeds per mag- STERILE
• 00813787020686: C20 IsoLoader magazines in TPSII – 20 seeds per mag
• 00813787020679: IsoLoader magazines in TPSII - 20 seeds per mag
• 00813787020662: In-STANT magazines in TPSII Ind. - 20 seeds per mag - STERILE
• 00813787020655: In-STANT magazines in TPSII - 20 seeds per mag - STERILE
• 00813787020648: In-STANT magazines in TPSII - 20 seeds per mag
• 00813787020631: C20 in TPSII Ind. x = 10, 15 or 20 seeds per mag - STERILE
• 00813787020624: C20 in TPSII x = 10, 15 or 20 seeds per mag - STERILE
• 00813787020617: C20 in TPSII x = 10, 15 or 20 seeds per mag
• 00813787020600: C20 in FlatPack x = (1)10, (3)15 or (7)20 seeds per mag
• 00813787020594: VSM in TPSII Ind. x = 10, 15 or 20 seeds per mag - STERILE
• 00813787020587: VSM in TPSII x = 10, 15 or 20 seeds per mag - STERILE
• 00813787020570: VSM in TPSII x = 10, 15 or 20 seeds per mag
• 00813787020563: Mick magazines in TPSII Ind. x = (8)15, or (9)10 seeds per mag - STERILE
• 00813787020556: Mick magazines in TPS x = (8)15, or (9)10 seeds per mag - STERILE
• 00813787020549: Mick magazines in TPS x = (8)15, or (9)10 seeds per mag
• 00813787020532: High activity loose seeds for the Eye – STERILE
• 00813787020525: High activity loose seeds for the Eye
• 00813787020518: Loose seeds in a vial for 3rd party processing
• 00813787020013: Loose seeds in a vial - STERILE
• 00813787020006: Loose seeds in a vial