Nalu Medical, Inc.

Basic Information

• Brand Name: Nalu Medical, Inc.
• Primary DI: 00812537036656
• Version / Model: 23012-025
• Catalog Number: 23012-025
• Company Name: NALU MEDICAL, INC.
• Labeler DUNS: 067140761
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-15
• Public Version: 1
• Public Version Date: 2022-09-23
• Public Version Status: New
• Public Device Record Key: 5c4e6d3e-051a-4fcd-9497-3c9c21918900

Device Description

Stylet (Straight, 25 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: 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: 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
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	882.5880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65531	Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wireless connection	An implantable, 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), to transmit electrical impulses received transcutaneously from a skin surface electrode (not included) to the target nerves for the relief/treatment of acute and/or chronic intractable pain. It may include disposable devices associated with implantation and stabilization (e.g., introducer, stylet, adhesive pad).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10812537036653	GS1		5	In Commercial Distribution
Primary	00812537036656	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	25	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: -20 – 140 Degrees Fahrenheit