CoverEdge™ MRI

Basic Information

• Brand Name: CoverEdge™ MRI
• Primary DI: 08714729995814
• Version / Model: SC-8436-50
• Company Name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
• Labeler DUNS: 824951958
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-28
• Public Version: 1
• Public Version Date: 2021-01-05
• Public Version Status: New
• Public Device Record Key: 6fdec0e4-79ac-436f-9745-f455673a65a6

Device Description

Surgical Lead Kit

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• 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
LGW	Stimulator, spinal-cord, totally implanted for pain relief	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
63365	Implantable electrical stimulation system intraoperative test lead	A flexible wire intended to be used during open surgical implantation of an electrical stimulation system, and designed to conduct electrical impulses from an external (nonimplantable) pulse generator to the implantable electrode prior to full system implantation to ensure the electrode is positioned correctly, through intraoperative observation of the desired nerve response. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08714729995814	GS1

Premarket Submissions

Submission Number	Supplement Number
P030017	338

Device Sizes

Type	Value	Unit	Text
Length	50	Centimeter