BUR BUTLER

Basic Information

• Brand Name: BUR BUTLER
• Primary DI: E2358225RPC0
• Version / Model: 8225RPC
• Catalog Number: 8225RPC
• Company Name: SHOFU DENTAL CORPORATION
• Labeler DUNS: 054618202
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-03
• Public Version: 1
• Public Version Date: 2021-02-11
• Public Version Status: New
• Public Device Record Key: 7b38516b-7e93-4a28-af34-f937d466d980

Device Description

BUR BUTLER 25-HOLE (STANDARD)

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
DZP	INSTRUMENT, DIAMOND, DENTAL	Dental	872.4535	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40599	Instrument storage cabinet	A furniture-like device designed for general-purpose use, typically where surgery is practised and carried out, to store and possibly display surgical instruments and other devices/products which will be used during surgical examinations/procedures. It will typically consist of double doors with glass windows in them that close off the shelving, and multiple drawers where the instruments are kept. It can be made of stainless steel, plastic materials, glass and wood. This device will typically be used in operating and procedure rooms, including dental, ophthalmological clinics, and doctors surgeries.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E2358225RPC0	HIBCC

Customer Contacts

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