Ear Wax Removal Kit 12 Ct. Case 704

GUDID 00714646000675

Ear Wax Removal Kit 12 Ct. Case

Bionix, LLC

Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use Ear canal irrigation kit, single-use

• Primary Device ID: 00714646000675
• NIH Device Record Key: fb481b45-a8e3-4e65-a1e5-1fdb662384bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ear Wax Removal Kit 12 Ct. Case
• Version Model Number: 704
• Catalog Number: 704
• Company DUNS: 117844489
• Company Name: Bionix, LLC
• Device Count: 12
• DM Exempt: true
• 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: true

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
• 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
• 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	00714646000675 [Unit of Use]
GS1	10714646000672 [Primary]

FDA Product Code

• OGQ: Ear irrigation kit

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: 2022-11-04
• Device Publish Date: 2022-10-27

Devices Manufactured by Bionix, LLC

• 10714646000788 - SutureOut: 2024-05-01 SutureOut, 50ct
• 10714646001181 - SutureOut: 2024-05-01 SutureOut, 3ct Sample
• 10714646000771 - ShotBlocker: 2024-03-25 ShotBlocker 1,000 ct
• 00714646000804 - AlphaCleanse® Antimicrobial Wound Care System: 2024-01-08 AlphaCleanse® Antimicrobial Wound Care System
• 20859911004768 - ShotBlocker®: 2023-10-06 ShotBlocker 50ct
• 10859911004778 - ShotBlocker®: 2023-10-06 ShotBlocker 100ct
• 10714646001136 - ClearLook Lighted AngleLoop: 2023-08-21 ClearLook Lighted AngleLoop, 50 curettes
• 10714646001143 - ClearLook Lighted MicroLoop: 2023-08-21 ClearLook Lighted MicroLoop, 50 curettes