ShotBlocker® 8100

GUDID 10859911004778

ShotBlocker 100ct

Bionix, LLC

Injection site desensitizer, tactile, reusable

• Primary Device ID: 10859911004778
• NIH Device Record Key: 3b6804bd-6dd4-498f-b45b-c6f83fae64dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ShotBlocker®
• Version Model Number: 8100
• Catalog Number: 8100
• Company DUNS: 117844489
• Company Name: Bionix, LLC
• Device Count: 100
• DM Exempt: true
• Pre-market Exempt: true
• 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: true
• Expiration Date: false
• 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)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859911004771 [Primary]
GS1	10859911004778 [Unit of Use]

FDA Product Code

• LYG: MASSAGER, THERAPEUTIC, MANUAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-10-06
• Device Publish Date: 2021-12-16

On-Brand Devices [ShotBlocker®]

• 00859911004788: ShotBlocker 1 ct
• 10859911004761: ShotBlocker 100ct
• 10859911004051: Over the counter
• 00859911004047: ShotBlocker® 2000 ct. Retail
• 10859911004778: ShotBlocker 100ct
• 20859911004768: ShotBlocker 50ct
• 10714646000849: ShotBlocker® 2000 ct. Retail
• 10714646000665: 5 ct ShotBlocker