SMC-2

Basic Information

• Brand Name: SMC-2
• Primary DI: 04580406869914
• Version / Model: SMC-2
• Catalog Number: 56329
• Company Name: OSADA ELECTRIC CO.,LTD.
• Labeler DUNS: 690713813
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-07
• Public Version: 1
• Public Version Date: 2018-07-09
• Public Version Status: New
• Public Device Record Key: 297bb2d3-0ce7-47c3-adaa-98bf0ff686c9

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Liquid Chemical

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKX	HANDPIECE, DIRECT DRIVE, AC-POWERED	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37708	Remotely-driven surgical/dental system drive cable	A flexible device for transmitting rotational power from a remote surgical or dental drilling system motor/control unit to the drilling handpiece. The drive is designed so that the handpiece can be flexibly manipulated by the operator (the surgeon or dentist). The design is typically based on a rotating metal spun spiral cable within a protective sheath; this is commonly known as a Bowden cable. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04580406869914	GS1