Primado2

Basic Information

• Brand Name: Primado2
• Primary DI: 04560264560703
• Version / Model: P200-CRA
• Company Name: NAKANISHI INC.
• Labeler DUNS: 690710546
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 5
• Public Version Date: 2021-11-29
• Public Version Status: Update
• Public Device Record Key: a8ad06af-8b03-4a05-b0ba-0d6866909278
• Distribution End Date: 2021-08-25

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: No
• 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: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HBC	MOTOR, DRILL, ELECTRIC	Neurology	882.4360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44491	Multi-purpose surgical power tool system, line-powered	An assembly of devices designed to resect bones, tough tissues (e.g., cartilage, ligaments), and soft tissues during a surgical procedure; it is not dedicated to a specific clinical application. It includes a mains electricity (AC-powered) control unit which supplies low-voltage electricity, motors/handpieces/power tool attachments, and a variety of tools (e.g., drill bits, saw blades, burs, milling cutters, shavers, screwdriver bits, guide wires).	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04560264560703	GS1

Premarket Submissions

Submission Number	Supplement Number
K132264	000