OtoClear SprayWash System, Single Use Sample 27291

GUDID 00714646000736

OtoClear SprayWash System, Single Use Sample

Bionix, LLC

Ear canal irrigation kit, reusable

• Primary Device ID: 00714646000736
• NIH Device Record Key: ae4b3d0d-1f06-4a9b-a10b-26c511a128c0
• Commercial Distribution Discontinuation: 2025-09-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: OtoClear SprayWash System, Single Use Sample
• Version Model Number: 27291
• Catalog Number: 27291
• Company DUNS: 117844489
• Company Name: Bionix, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00714646000736 [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: 2025-09-09
• Device Publish Date: 2024-07-11

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• 00714646001498 - Pelvis Belly Replacement Stomach Cushion - Medium: 2025-08-29 Pelvis Belly Replacement Stomach Cushion - Medium
• 00714646001504 - Pelvis Belly Replacement Face Cushion Assembly: 2025-08-29 Pelvis Belly Replacement Face Cushion Assembly
• 00714646001511 - Pelvis Belly Replacement Stomach Cushion - Small: 2025-08-29 Pelvis Belly Replacement Stomach Cushion - Small
• 10714646001099 - Microsuction Stater Pack: 2025-07-16 Microsuction Starter Pack