POWEREASE™ Instruments

Basic Information

• Brand Name: POWEREASE™ Instruments
• Primary DI: 00613994917676
• Version / Model: 2346010
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Labeler DUNS: 830350380
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-16
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: ac424b28-1bd8-40ee-8d5c-1b16e36f76d8

Device Description

BREAKOFF 2346010 SET SCREW BREAKOFF

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: 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
GWF	STIMULATOR, ELECTRICAL, EVOKED RESPONSE	Neurology	882.1870	2
HBE	DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)	Neurology	882.4310	2
HWE	INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47858	Surgical instrument torque limiter	A small device designed to attach to a surgical power tool (e.g., the proximal end of a surgical drill handpiece) or a manual surgical instrument (e.g., a screwdriver) to define the torque effect of that tool allowing the surgeon to apply the correct torque, e.g., when tightening an orthopaedic fixation screw during a surgical intervention. It is typically made of high-grade stainless steel or synthetic materials and includes a built-in clutch mechanism. It is available in various shapes, sizes and torque ranges. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00613994917676	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K111520	000