Sample, Lighted Placement Tool

Basic Information

• Brand Name: Sample, Lighted Placement Tool
• Primary DI: 00714646001030
• Version / Model: SP-22850
• Catalog Number: 22850
• Company Name: Bionix, LLC
• Labeler DUNS: 117844489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-27
• Public Version: 2
• Public Version Date: 2023-06-19
• Public Version Status: Update
• Public Device Record Key: 600430a2-bdf0-431f-bc83-2f654f24ab24

Device Description

Sample, 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: Yes
• 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
Primary	00714646001030	GS1

Customer Contacts

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