Bigfoot Pen Needles FG-300161

GUDID 00850003506067

Bigfoot Pen Needles, 4mm 32G, 100CT

Bigfoot Biomedical, Inc.

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• Primary Device ID: 00850003506067
• NIH Device Record Key: 6b3662d8-21bc-4147-99ed-082bca17d35f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bigfoot Pen Needles
• Version Model Number: FG-300161
• Catalog Number: FG-300161
• Company DUNS: 079721177
• Company Name: Bigfoot Biomedical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com
• Phone: 551-244-3668
• Email: customercare@bigfootbiomedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003506067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152339

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-07
• Device Publish Date: 2021-06-29

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• 00850003506593 - Bigfoot Unity: 2023-07-20 Bigfoot Unity Support Kit
• 00850003506531 - Bigfoot Unity: 2023-04-11 Bigfoot Unity Pen Cap for Lispro
• 00850003506548 - Bigfoot Unity: 2023-04-11 Bigfoot Unity Pen Cap for Lyumjev
• 00850003506555 - Bigfoot Unity: 2023-04-11 Bigfoot Unity Pen Cap for Admelog
• 00850003506562 - Bigfoot Unity: 2023-04-11 Bigfoot Unity Pen Cap for Aspart