Orange ControLoop®

Basic Information

• Brand Name: Orange ControLoop®
• Primary DI: 00859911004436
• Version / Model: 2999
• Catalog Number: 2999
• Company Name: Bionix, LLC
• Labeler DUNS: 117844489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2021-12-10
• Public Version: 3
• Public Version Date: 2023-07-17
• Public Version Status: Update
• Public Device Record Key: eb3f106e-dc5d-4cc0-971b-e13b492e50b1

Device Description

Curette used for safe cerumen removal

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: Yes
• 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
65445	Endaural wax extraction curette	A hand-held, manual, non-surgical device intended to scrape within the ear canal primarily for the extraction of ear wax during an ear/nose/throat (ENT) procedure; it is not intended for surgical scraping or manipulation of tissues. It may have various designs (e.g., serrated or blunt loop, hook, straight or curved), and may include a magnifying lens and/or light source. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10859911004433	GS1
Primary	00859911004436	GS1

Customer Contacts

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