Screwdriver

Basic Information

• Brand Name: Screwdriver
• Primary DI: 08031527009230
• Version / Model: ICD
• Company Name: MICROPORT CRM SRL
• Labeler DUNS: 438860859
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-05
• Public Version: 3
• Public Version Date: 2020-10-20
• Public Version Status: Update
• Public Device Record Key: 626f7163-c9e7-4c07-85f4-301d08e3abbf

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MRM	DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
46223	Pacing/defibrillation lead setscrew	A sterile device designed to secure the attached pacing lead terminal(s) in the header connector (connection socket) of an implantable pacing device (e.g., an implanted pacemaker or defibrillator) during the implantation procedure. It is typically made of high-grade stainless steel or titanium (Ti). The device is typically available in a set of graduated sizes. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08031527009230	GS1