Octrode®

Basic Information

• Brand Name: Octrode®
• Primary DI: 05414734401692
• Version / Model: 3183
• Catalog Number: 3183
• Company Name: ADVANCED NEUROMODULATION SYSTEMS, INC.
• Labeler DUNS: 021675699
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-10-22
• Public Version: 5
• Public Version Date: 2023-01-09
• Public Version Status: Update
• Public Device Record Key: 4acae6a2-b444-42c0-929a-2adbaeff903e

Device Description

Lead Kit, 30cm Length

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: Yes
• Has Lot/Batch Number: No
• 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
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	05414734401692	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P010032	000

Device Sizes

Type	Value	Unit	Text
Length	30	Centimeter

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 150 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 150 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity