Sample, Lighted Placement Tool 22850

GUDID 00714646001030

Sample, Lighted Placement Tool

Bionix, LLC

Earmould impression block insertion tool

• Primary Device ID: 00714646001030
• NIH Device Record Key: 600430a2-bdf0-431f-bc83-2f654f24ab24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sample, Lighted Placement Tool
• Version Model Number: SP-22850
• Catalog Number: 22850
• 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	00714646001030 [Primary]

FDA Product Code

• JYG: CURETTE, EAR

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

• 00714646000606 - Igloo Wound Irrigator: 2024-10-03 Wound Irrigation - Sample
• 10714646000665 - ShotBlocker®: 2024-09-26 5 ct ShotBlocker
• 10714646000849 - ShotBlocker®: 2024-09-26 ShotBlocker® 2000 ct. Retail
• 20714646000860 - SafeStraw™ 2 Pack: 2024-09-26 SafeStraw™ 2 Pack
• 10714646000993 - Opti-Tatt™ Dots: 2024-09-26 Opti-Tatt, Dot, Sheet of 24
• 10714646001006 - Opti-Tatt™ Crosshairs: 2024-09-26 Opti-Tatt, Crosshair, Sheet of 24
• 10714646001013 - Opti-Tatt™ Field Borders: 2024-09-26 Opti-Tatt, Field Border, Sheet of 24
• 10714646001020 - Sample: Opti-Tatt Dots: 2024-09-26 Sample: Opti-Tatt, Dot, Sheet of 3