Nalu Medical, Inc.

Basic Information

• Brand Name: Nalu Medical, Inc.
• Primary DI: 00812537036236
• Version / Model: 12009-040-US
• Catalog Number: 12009-040-US
• Company Name: NALU MEDICAL, INC.
• Labeler DUNS: 067140761
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-23
• Public Version: 1
• Public Version Date: 2021-08-02
• Public Version Status: New
• Public Device Record Key: 8366daad-e097-4741-87c8-7f120e03a7e7

Device Description

Trial Lead (4 contact, 40 cm)

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 Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)	Neurology	882.5870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65533	Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system lead	An invasive, electrically-insulated wire with a distal electrode intended to be introduced into the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) for percutaneous wired transmission of electrical impulses from an external pulse generator, to the target nerves, for analgesia during a trial period (<= 30 days). It is designed to validate therapy/test operating parameters prior to introduction of a permanent implantable analgesic electrical stimulation system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812537036236	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	40	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Storage Environment Temperature
• Temperature Range: 14 – 131 Degrees Fahrenheit