Model 200 TheraSeed® Palladium-103 Loose Seed TS200K

GUDID 00801741078477

PD103 Loose Seeds, Non-Sterile, Calibrated

Bard Brachytherapy, Inc.

Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant

• Primary Device ID: 00801741078477
• NIH Device Record Key: 5f7e2b03-357f-4d27-85a4-5a27462e371b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Model 200 TheraSeed® Palladium-103 Loose Seed
• Version Model Number: TS200K
• Catalog Number: TS200K
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741078477 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010283

FDA Product Code

• KXK: Source, brachytherapy, radionuclide

Sterilization

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

[00801741078477]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078477]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078477]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078477]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078477]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078477]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078477]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078477]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078477]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078477]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078477]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078477]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078477]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078477]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078477]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078477]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078477]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078477]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078477]

Moist Heat or Steam Sterilization;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-05

On-Brand Devices [Model 200 TheraSeed® Palladium-103 Loose Seed]

• 00801741078484: PD103 Loose Seeds, Sterile, Calibrated
• 00801741078477: PD103 Loose Seeds, Non-Sterile, Calibrated
• 00801741078392: PD103 Loose Seeds, Sterile
• 00801741078385: PD103 Loose Seeds, Non-Sterile