Spiro® Colorinox® Sterile

Basic Information

• Brand Name: Spiro® Colorinox® Sterile
• Primary DI: J003A004B021050011
• Version / Model: A004B02105001
• Catalog Number: A004B02105001
• Company Name: MAILLEFER INSTRUMENTS HOLDING Sàrl
• Labeler DUNS: 480538495
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-30
• Public Version: 1
• Public Version Date: 2022-10-10
• Public Version Status: New
• Public Device Record Key: cb454dd9-0a70-470c-96a7-069c0592617f

Device Description

Endodontic Instrument, Barbed broach

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKW	BROACH, ENDODONTIC	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63202	Endodontic broach, serrated, single-use	A hand-held, manual, dental, cutting instrument with a slender, tapered, serrated/barbed tip intended to be used for shaping and enlarging holes in root canal tissue, particularly dentine, or for extirpating pulp. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J003A004B021050011	HIBCC

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: N/A