QuickLink™ Cartridge 5.5mm Standard SourceLink™ 70301QC5

GUDID 10801741078061

QuickLink™ Cartridge 5.5mm Standard SourceLink™ Synthetic Absorbable Seeding Spacer Links #5

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

• Primary Device ID: 10801741078061
• NIH Device Record Key: b2419af1-1c34-4f84-aae2-1a903f0e1b44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuickLink™ Cartridge 5.5mm Standard SourceLink™
• Version Model Number: 70301QC5
• Catalog Number: 70301QC5
• Company DUNS: 185524860
• Company Name: Bard Brachytherapy, Inc.
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741078064 [Unit of Use]
GS1	10801741078061 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-10-31
• Device Publish Date: 2015-10-05

On-Brand Devices [QuickLink™ Cartridge 5.5mm Standard SourceLink™]

• 10801741078078: QuickLink™ Cartridge 5.5mm Standard SourceLink™ Synthetic Absorbable Seeding Spacer Links #2
• 10801741078061: QuickLink™ Cartridge 5.5mm Standard SourceLink™ Synthetic Absorbable Seeding Spacer Links #5