Thin SeedTM Iodine-126 9011-TSRx-ROUND

GUDID 00840682100762

MEDI-PHYSICS, INC.

Manual brachytherapy source, permanent implant

• Primary Device ID: 00840682100762
• NIH Device Record Key: 0472d29c-374d-4d23-b505-275437e1bd50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thin SeedTM Iodine-126
• Version Model Number: 9011 TSRx Braided Round Needle
• Catalog Number: 9011-TSRx-ROUND
• Company DUNS: 059470927
• Company Name: MEDI-PHYSICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: +1(800)228-0126
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682100762 [Primary]

FDA Product Code

• KXK: Source, brachytherapy, radionuclide

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-09-24

Devices Manufactured by MEDI-PHYSICS, INC.

• 00840682100403 - OncoSeedTM: 2018-03-29
• 00840682100427 - I-125 SeedTM Sterile Convenience Pack: 2018-03-29
• 00840682100434 - I-125 SeedTM Sterile Convenience Pack: 2018-03-29
• 00840682100441 - OncoSeedTM: 2018-03-29
• 00840682100458 - RAPID StrandTM Rx: 2018-03-29
• 00840682100465 - Thin SeedTM: 2018-03-29
• 00840682100472 - OncoSeedTM: 2018-03-29
• 00840682100489 - OncoSeedTM: 2018-03-29