ATOZ Screwdriver

Basic Information

• Brand Name: ATOZ Screwdriver
• Primary DI: 08800197900051
• Version / Model: MKD-L and MKD-S
• Company Name: MK Meditech Inc.
• Labeler DUNS: 695009476
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-22
• Public Version: 1
• Public Version Date: 2022-01-31
• Public Version Status: New
• Public Device Record Key: cbbe1e69-57b7-48b4-94e6-f1fb174903b7

Device Description

PRODUCT SUMMARY This is used for insertion and removal of the ATOZ Mini-screw. The driver is designed just for MK Mini-screw (MKS-1611, MKS-1613), so it does not fit other types of mini-screws. INDICATION FOR USE This is used for insertion and removal of the ATOZ Mini-screw TRADE NAME ATOZ Screwdriver MODEL NAME MKD-S and MKD-L COSIST OF MKD-S *1EA + MKD-L*1EA

Device Characteristics

• Single Use: Yes
• 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
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33968	Surgical screwdriver, reusable	A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800197900051	GS1