Sample, OtoClear® Ear Irrigation System (220V) 27247

GUDID 00714646000989

Sample, OtoClear® Ear Irrigation System (220V)

Bionix, LLC

Ear canal lavage system

• Primary Device ID: 00714646000989
• NIH Device Record Key: 4be4c7b5-fe60-460b-bfa3-a32644325f1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sample, OtoClear® Ear Irrigation System (220V)
• Version Model Number: SP-27247
• Catalog Number: 27247
• 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: 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	00714646000989 [Primary]

FDA Product Code

• LRD: APPLICATOR, ENT DRUG

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-06-19
• Device Publish Date: 2022-10-27

Devices Manufactured by Bionix, LLC

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• 10714646000566 - Sample, Safe Ear Curette Rainbow Pack: 2024-07-18 Sample, Safe Ear Curette Rainbow Pack
• 10714646000641 - Lighted Ear Curette Demo Pack (monthly mailer): 2024-07-18 Lighted Ear Curette Demo Pack (monthly mailer)
• 00714646001085 - Sample, Lighted Suction Handle: 2024-07-18 Sample, Lighted Suction Handle
• 00714646001252 - Lighted Articulating - Sample: 2024-06-24 Lighted Articulating Curette - Sample
• 10714646001198 - SecureFoam: 2024-06-10 SecureFoam - Small
• 10714646001204 - SecureFoam: 2024-06-10 SecureFoam - Medium