Sample, Lighted FlexLoop 22205

GUDID 00714646000552

Sample, Lighted FlexLoop

Bionix, LLC

ENT illuminating foreign body extraction set

• Primary Device ID: 00714646000552
• NIH Device Record Key: b67ef393-6105-4ebc-b8eb-3af37a0b5a14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sample, Lighted FlexLoop
• Version Model Number: 22205
• Catalog Number: 22205
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00714646000552 [Primary]

FDA Product Code

• JYG: CURETTE, EAR

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: 2024-07-18
• Device Publish Date: 2024-07-10

Devices Manufactured by Bionix, LLC

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• 10714646001310 - ClearLook Lighted MicroLoop, Refill: 2025-03-05 ClearLook Lighted MicroLoop, 50ct Refill
• 10714646001327 - ClearLook Lighted VersaLoop, Refill: 2025-03-05 ClearLook Lighted VersaLoop, 50ct Refill
• 10714646001334 - ClearLook Lighted FlexLoop, Refill: 2025-03-05 ClearLook Lighted FlexLoop, 50ct Refill
• 10714646001341 - ClearLook Lighted Variety Pack, Refill: 2025-03-05 ClearLook Lighted Variety Pack, 50ct Refill
• 10714646001358 - ClearLook Lighted InfantScoop, Refill: 2025-03-05 ClearLook Lighted InfantScoop, 50ct Refill
• 10714646001365 - ClearLook Lighted Variety Pack with Rechargeable Light Source: 2025-03-05 ClearLook Lighted Variety Pack with Rechargeable Light Source