Bionix Development Corporation

Basic Information

• Brand Name: Bionix Development Corporation
• Primary DI: 00859911004191
• Version / Model: 9877
• Catalog Number: 9877
• Company Name: Bionix, LLC
• Labeler DUNS: 117844489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 48
• Record Status: Published
• Publish Date: 2017-01-28
• Public Version: 5
• Public Version Date: 2023-07-18
• Public Version Status: Update
• Public Device Record Key: da703d68-76ff-412f-a315-bd7447ec624a

Device Description

Disposable Speculum-48 count

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
EPY	SPECULUM, ENT	General, Plastic Surgery	878.1800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42449	Nasal speculum, single-use	A hand-held surgical instrument which is inserted into a nostril and manually expanded to open the nostril to a maximum by stretching the tissue around the nasal orifice allowing the doctor or surgeon access for examination or surgery during ear/nose/throat (ENT) intervention. It is made of disposable materials and has two blunt, contoured blades that are operated by the operator applying pressure to the pivoted handles or other mechanism. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859911004191	GS1
Unit of Use	10859911004198	GS1

Customer Contacts

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