Bard® BrachySource® I-125 Implant Seed PS1251L

GUDID 00801741078194

BrachySource® I125 Loose Seeds, Non-Sterile

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

• Primary Device ID: 00801741078194
• NIH Device Record Key: 1484e7f7-d4b1-4821-8bdb-01d94ec24a76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bard® BrachySource® I-125 Implant Seed
• Version Model Number: PS1251L
• Catalog Number: PS1251L
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741078194 [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

[00801741078194]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078194]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078194]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078194]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078194]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078194]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078194]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078194]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078194]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078194]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078194]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078194]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078194]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078194]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078194]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00801741078194]

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: 2015-09-29

On-Brand Devices [Bard® BrachySource® I-125 Implant Seed]

• 00801741078309: BrachySource® I125 Loose Seeds, Sterile, Calibrated
• 00801741078293: BrachySource® I125 Loose Seeds, Non-Sterile, Calibrated
• 00801741078200: BrachySource® I125 Loose Seeds, Sterile
• 00801741078194: BrachySource® I125 Loose Seeds, Non-Sterile