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

• 00714646001474 - Pelvis Belly Replacement Leg Cushion: 2025-08-29 Pelvis Belly Replacement Leg Cushion
• 00714646001481 - Pelvis Belly Replacement Arm Rest Cushion: 2025-08-29 Pelvis Belly Replacement Arm Rest Cushion
• 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
• 10714646001105 - Microsuction Replacement Pack: 2025-07-16 Microsuction Replacement Pack
• 10714646001129 - Sample: Opti-Tatt: 2025-06-30 Opti-Tatt Sample - 2 Dot, 2 Crosshair, 2 Field Border