Bard® BrachySource® I-125 Implant Seeds In Cartridges 1251CSRAF

GUDID 00801741078286

BrachySource® I125 SEEDS IN MICK SourceCaps™ MAG, STERILE FOR ASSAY

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

• Primary Device ID: 00801741078286
• NIH Device Record Key: aa9d455f-4601-441a-822a-32b3ce76ca92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bard® BrachySource® I-125 Implant Seeds In Cartridges
• Version Model Number: 1251CSRAF
• Catalog Number: 1251CSRAF
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741078286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140856

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-10-05

On-Brand Devices [Bard® BrachySource® I-125 Implant Seeds In Cartridges]

• 00801741078286: BrachySource® I125 SEEDS IN MICK SourceCaps™ MAG, STERILE FOR ASSAY
• 00801741078279: BrachySource® I125 SEEDS IN MICK DISPOSABLE 15, STERILE FOR ASSAY
• 00801741078262: BrachySource® I125 Seeds loaded in Reusable Mick magazine, STERILE
• 00801741078255: BrachySource® I125 SEEDS LOADED W SourceCaps™ IN MICK CRTDG, STERILE W PRELOADED NEEDLES
• 00801741078248: BrachySource® I125 SEEDS LOADED W SourceCaps™ IN MICK CRTDG, STERILE
• 00801741078231: BrachySource® I125 SEEDS IN MICK CRTDG, STERILE W/ PRELD NEEDLES
• 00801741078224: BrachySource® I125 SEEDS IN MICK CRTDG, STERILE
• 00801741078217: BrachySource® I125 SEEDS IN MICK CRTDG, NON-STERILE