Lighted Placement Tool

Basic Information

• Brand Name: Lighted Placement Tool
• Primary DI: 00859911004726
• Version / Model: 2850
• Catalog Number: 2850
• Company Name: Bionix, LLC
• Labeler DUNS: 117844489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 15
• Record Status: Published
• Publish Date: 2022-08-08
• Public Version: 4
• Public Version Date: 2023-08-11
• Public Version Status: Update
• Public Device Record Key: da88d8b3-f6ed-4391-99e9-3962c36104c4

Device Description

Lighted Placement Tool

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JYG	CURETTE, EAR	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41238	Earmould impression block insertion tool	A hand-held, electrically-powered device intended to assist placement of a block (tamp) which limits the passage of earmould impression material when taking an ear canal impression. It consists of a disposable transparent probe illuminated with a reusable light source, to which a magnifying lens may be attached.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10859911004723	GS1
Primary	00859911004726	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]