Bard® BrachySource® I-125 Implant Seeds In ReadyLink™ STM1251RL

GUDID 00801741078347

BrachySource® I125 SEEDS AND SourceLinks™ IN THE ReadyLink™ CONFIG, STERILE

Bard Brachytherapy, Inc.

Brachytherapy source spacer

• Primary Device ID: 00801741078347
• NIH Device Record Key: a4047bff-ba4c-43b3-8439-9cc754766976
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bard® BrachySource® I-125 Implant Seeds In ReadyLink™
• Version Model Number: STM1251RL
• Catalog Number: STM1251RL
• Company DUNS: 185524860
• Company Name: Bard Brachytherapy, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• 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)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com
• Phone: +1(800)977-6733
• Email: medical.services@crbard.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741078347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093663

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: 2015-10-05

Devices Manufactured by Bard Brachytherapy, Inc.

• 10801741078122 - QuickLink™: 2024-09-09 QuickLink™ Cartridge 5.5 mm Spacer
• 10801741078061 - QuickLink™ Cartridge 5.5mm Standard SourceLink™: 2022-10-31 QuickLink™ Cartridge 5.5mm Standard SourceLink™ Synthetic Absorbable Seeding Spacer Links #5
• 10801741078078 - QuickLink™ Cartridge 5.5mm Standard SourceLink™: 2022-10-31 QuickLink™ Cartridge 5.5mm Standard SourceLink™ Synthetic Absorbable Seeding Spacer Links #20
• 10801741078085 - QuickLink™ Cartridge 0.5mm Seed-to-Seed SourceLink™: 2022-10-31 QuickLink™ Cartridge 0.5mm Seed-to-Seed SourceLink™ Synthetic Absorbable Seeding Spacer Links #5
• 10801741078092 - QuickLink™ Cartridge 0.5mm Seed-to-Seed SourceLink™: 2022-10-31 QuickLink™ Cartridge 0.5mm Seed-to-Seed SourceLink™ Synthetic Absorbable Seeding Spacer Links #10
• 10801741078108 - QuickLink™ Cartridge 5.0mm Extension SourceLink™: 2022-10-31 QuickLink™ Cartridge 5.0mm Extension SourceLink™ Synthetic Absorbable Seeding Spacer Links #10
• 10801741078115 - QuickLink™ Cartridge 5.0mm Extension SourceLink™: 2022-10-31 QuickLink™ Cartridge 5.0mm Extension SourceLink™ Synthetic Absorbable Seeding Spacer Links #20
• 10801741078139 - SourceLink™ 5.5mm Standard SourceLink™: 2022-10-31 SourceLink™ 5.5mm Standard SourceLink™ - Model 7030120 Synthetic Absorbable Seeding Spacer Links, 20 ea.