Lighted Ear Curette Demo Pack (monthly mailer) 22201

GUDID 10714646000641

Lighted Ear Curette Demo Pack (monthly mailer)

Bionix, LLC

ENT illuminating foreign body extraction set

• Primary Device ID: 10714646000641
• NIH Device Record Key: eb09f7f6-dc38-4549-9721-924473330125
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lighted Ear Curette Demo Pack (monthly mailer)
• Version Model Number: 22201
• Catalog Number: 22201
• Company DUNS: 117844489
• Company Name: Bionix, LLC
• Device Count: 8
• DM Exempt: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00714646000644 [Primary]
GS1	10714646000641 [Unit of Use]

FDA Product Code

• JYG: CURETTE, EAR

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-18
• Device Publish Date: 2024-07-10

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