SourceLink 5.0mm Spacer 7030550

GUDID 00801741184130

5.0mm Spacer, Sterile Pack of 50

Bard Brachytherapy, Inc.

Brachytherapy source spacer

• Primary Device ID: 00801741184130
• NIH Device Record Key: b1dcb71e-0053-4f3c-9f07-e5b1af588030
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SourceLink 5.0mm Spacer
• Version Model Number: 7030550
• Catalog Number: 7030550
• Company DUNS: 185524860
• Company Name: Bard Brachytherapy, Inc.
• Device Count: 50
• 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: 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

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
• 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

Device Dimensions

• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter
• Length: 5 Millimeter

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
• 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	00801741184130 [Unit of Use]
GS1	10801741184137 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023210

FDA Product Code

• KXK: Source, brachytherapy, radionuclide

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-14
• Device Publish Date: 2020-08-06

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.