Model 200 TheraSeed® Palladium-103 Device in Cartridges 200CNF

GUDID 00801741078446

Model 200 TheaSeed® Palladium-103 SEEDS LOADED W SourceCaps IN MICK CRTDG, STERILE W PRELOADED NEEDLES

Bard Brachytherapy, Inc.

Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer Brachytherapy source spacer

• Primary Device ID: 00801741078446
• NIH Device Record Key: 30aee0e3-4457-4e06-a8c3-7d836b9bfd2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Model 200 TheraSeed® Palladium-103 Device in Cartridges
• Version Model Number: 200CNF
• Catalog Number: 200CNF
• Company DUNS: 185524860
• Company Name: Bard Brachytherapy, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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
• 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
• Storage Environment Temperature: Between 0 and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741078446 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060636

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.

• 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.
• 10801741078146 - SourceLink™ 0.5mm Seed-to-Seed SourceLink™: 2022-10-31 SourceLink™ 0.5mm Seed-to-Seed SourceLink™ - Model 7030205 Synthetic Absorbable Seeding Spacer Links, 5 ea