Nalu Medical, Inc.

Basic Information

• Brand Name: Nalu Medical, Inc.
• Primary DI: 00812537035536
• Version / Model: 72005-US
• Catalog Number: 72005-US
• Company Name: NALU MEDICAL, INC.
• Labeler DUNS: 067140761
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-21
• Public Version: 2
• Public Version Date: 2020-06-25
• Public Version Status: Update
• Public Device Record Key: e0d4755f-1faf-4f61-be11-dad9d1d3b1a7
• Distribution End Date: 2020-06-24

Device Description

Lead Extension Kit (4)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
38474	Analgesic implantable peripheral nerve electrical stimulation system	An assembly of devices designed to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. It typically consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812537035536	GS1

Customer Contacts

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

Storage Conditions

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