Bard® BrachySource® I-125 Loose Seed with SourceLink™ Pack 1251LINKL

GUDID 00801741078316

BrachySource® I125 LOOSE SEEDS, W SourceLinks™, Non-Sterile

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

• Primary Device ID: 00801741078316
• NIH Device Record Key: ce9fcb5a-a74a-4cc7-8675-9fb5bcf65ff6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bard® BrachySource® I-125 Loose Seed with SourceLink™ Pack
• Version Model Number: 1251LINKL
• Catalog Number: 1251LINKL
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741078316 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093663

FDA Product Code

• KXK: Source, brachytherapy, radionuclide

Sterilization

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

[00801741078316]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078316]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078316]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078316]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078316]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078316]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078316]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078316]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078316]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078316]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078316]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078316]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078316]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078316]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078316]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078316]

Moist Heat or Steam Sterilization;Ethylene Oxide

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

On-Brand Devices [Bard® BrachySource® I-125 Loose Seed with SourceLink™ Pack]

• 00801741078323: BrachySource® I125 LOOSE SEEDS , W SourceLinks™, STERILE
• 00801741078316: BrachySource® I125 LOOSE SEEDS, W SourceLinks™, Non-Sterile