OtoClear SprayWash Adapter Wand 27219

GUDID 00859911004818

SprayWash Adapter Wand

Bionix, LLC

Ear canal irrigation kit, reusable

• Primary Device ID: 00859911004818
• NIH Device Record Key: 2eafa4e9-431c-458f-811a-6fb94d4f5b8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OtoClear SprayWash Adapter Wand
• Version Model Number: 27219
• Catalog Number: 27219
• Company DUNS: 117844489
• Company Name: Bionix, LLC
• Device Count: 1
• 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: false
• 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
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859911004818 [Primary]

FDA Product Code

• KCP: SYRINGE, ENT

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: 2023-07-31
• Device Publish Date: 2023-07-21

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• 10714646001204 - SecureFoam: 2024-06-10 SecureFoam - Medium