BOSS Instruments

Basic Information

• Brand Name: BOSS Instruments
• Primary DI: 00888515228450
• Version / Model: 90-3204
• Catalog Number: 90-3204
• Company Name: BOSS INSTRUMENTS, LTD., INC.
• Labeler DUNS: 848522678
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-27
• Public Version: 1
• Public Version Date: 2024-03-06
• Public Version Status: New
• Public Device Record Key: 59cdb902-55d7-4274-b204-a47b4a235840

Device Description

Whirley Bird Knife No. 4, left, 5 7/8"

Device Characteristics

• Single Use: No
• 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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KTG	KNIFE, ENT	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12245	Ear knife	A hand-held manual surgical instrument intended to cut and dissect tissues of the ear during a surgical intervention. It is typically designed as a one-piece instrument with a sharp, single-edged, cutting blade at the distal end; this is normally quite small and may be of various shapes, and has a long slender shaft with a handle at the proximal end. It is normally made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888515228450	GS1

Customer Contacts

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