NA

Basic Information

• Brand Name: NA
• Primary DI: 00643169157361
• Version / Model: 387345
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 796986144
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-06-08
• Public Version: 4
• Public Version Date: 2023-01-13
• Public Version Status: Update
• Public Device Record Key: 4b53b61c-9a7d-4814-bbe7-2231487d094c
• Distribution End Date: 2023-01-02

Device Description

LEAD 387345 OCTAD 1X8 BNT STYLET EMAN US

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GZB	STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)	Neurology	882.5880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62423	Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection	An electrically-insulated wire with a distal electrode intended to be implanted into the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) for wired transmission of electrical impulses from a co-implanted pulse generator (not included), to the target nerves, for the relief/treatment of acute and/or chronic intractable pain.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00643169157361	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K051773	000

Device Sizes

Type	Value	Unit	Text
Length	45.0	Centimeter