Primado2

Basic Information

• Brand Name: Primado2
• Primary DI: 04560264561397
• Version / Model: PD-RA-M
• Company Name: NAKANISHI INC.
• Labeler DUNS: 690710546
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 6
• Public Version Date: 2023-11-21
• Public Version Status: Update
• Public Device Record Key: 9e2c9809-2371-4c26-ae23-aecf122b97f8

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: Yes
• 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
64570	Reaming power tool attachment	A small component of a powered reaming assembly intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a reaming function when an appropriate reamer endpiece (not included) is inserted. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04560264561397	GS1
Direct Marking	04589551352739	GS1

Premarket Submissions

Submission Number	Supplement Number
K132264	000