NA

Basic Information

• Brand Name: NA
• Primary DI: 05414734400107
• Version / Model: 1112
• Catalog Number: 1112
• Company Name: ADVANCED NEUROMODULATION SYSTEMS, INC.
• Labeler DUNS: 021675699
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-11-12
• Public Version: 4
• Public Version Date: 2023-01-09
• Public Version Status: Update
• Public Device Record Key: 1d2277e7-138f-49e5-b2e5-e59509a8c358

Device Description

Tunneling Tool, 12"

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: 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
34827	Tendon/ligament tunneller	A long, hand-held, manual surgical instrument designed to tunnel an artificial passageway along ligament and/or tendon tissue to create a connecting channel. It can have a variety of designs: 1) a long, round, stiff rod that tapers to a rounded point at the distal tip with a handle at the proximal end to allow the surgeon to exert the necessary pressure and manipulation to push it through the body tissue; or 2) a ring-handled instrument with long, slightly curved arms that join at a pivot point near the distal end, terminating in short grasping arms. It will typically be made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	15414734400104	GS1		5	In Commercial Distribution
Primary	05414734400107	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P010032	000

Device Sizes

Type	Value	Unit	Text
Length	12	Inch

Storage Conditions

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