Extended Torque Wrench

Basic Information

• Brand Name: Extended Torque Wrench
• Primary DI: 00812537037462
• Version / Model: 23005-003
• Company Name: NALU MEDICAL, INC.
• Labeler DUNS: 067140761
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-26
• Public Version: 2
• Public Version Date: 2026-04-01
• Public Version Status: Update
• Public Device Record Key: 476b03a8-5ac6-4b61-aef5-2b2d24211df7
• Distribution End Date: 2026-03-31

Device Description

A torque limited hex driver that is used to tighten the connector set screws and the Anchor.

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
32871	Surgical torque wrench, reusable	A hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812537037462	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 140 Degrees Fahrenheit