Bard® BrachySource® I-125 Implant Seed Preloaded in Needles 1251PAP

GUDID 00801741098604

Preloaded Needle Kits all consist of products (BrachySource® Iodine seeds, SourceLink™, Spacers) loaded into Brachytherapy needles

Bard Brachytherapy, Inc.

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• Primary Device ID: 00801741098604
• NIH Device Record Key: 1585767f-1d55-475e-966f-a84ee4f29ee8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bard® BrachySource® I-125 Implant Seed Preloaded in Needles
• Version Model Number: 1251PAP
• Catalog Number: 1251PAP
• 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	00801741098604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093663

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 Seed Preloaded in Needles]

• 00801741098697: Preloaded Needle Kits all consist of products (BrachySource® Iodine seeds, SourceLink™, Space
• 00801741098611: Preloaded Needle Kits all consist of products (BrachySource® Iodine seeds, SourceLink™, Sourc
• 00801741098604: Preloaded Needle Kits all consist of products (BrachySource® Iodine seeds, SourceLink™, Space
• 00801741098598: Preloaded Needle Kits all consist of products (BrachySource® Iodine seeds, SourceLink™, Space
• 00801741098581: Preloaded Needle Kits all consist of products (BrachySource® Iodine seeds, SourceLink™, Sourc
• 00801741098376: Preloaded Needle Kits all consist of products (BrachySource® Iodine seeds, SourceLink™, Space
• 00801741086779: Preloaded Needle Kits all consist of products (BrachySource® Iodine seeds, SourceLink™, Space