Model 200 TheraSeed® Palladium-103 Loose Seed with SourceLink™ Pack 200LINKL

GUDID 00801741078491

Model 200 TheraSeed® Palladium-103 LOOSE SEEDS, W pack of SourceLink™

Bard Brachytherapy, Inc.

Manual brachytherapy source, permanent implant

• Primary Device ID: 00801741078491
• NIH Device Record Key: 74a060d5-9f89-4198-9bda-3f7dec83b453
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Model 200 TheraSeed® Palladium-103 Loose Seed with SourceLink™ Pack
• Version Model Number: 200LINKL
• Catalog Number: 200LINKL
• 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
• 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
• 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	00801741078491 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060636

FDA Product Code

• KXK: Source, brachytherapy, radionuclide

Sterilization

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

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078491]

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 [Model 200 TheraSeed® Palladium-103 Loose Seed with SourceLink™ Pack]

• 00801741078507: Model 200 TheraSeed® Palladium-103 LOOSE SEEDS , W SourceLink™ Pack, STERILE
• 00801741078491: Model 200 TheraSeed® Palladium-103 LOOSE SEEDS, W pack of SourceLink™