Introducer 6" Length

Basic Information

• Brand Name: Introducer 6" Length
• Primary DI: 00818225020501
• Version / Model: MD0495-A
• Company Name: STIMWAVE TECHNOLOGIES INCORPORATED
• Labeler DUNS: 078294927
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-25
• Public Version: 1
• Public Version Date: 2018-11-26
• Public Version Status: New
• Public Device Record Key: c11d129c-e84b-456e-a1ba-0d24bf6d5f5c

Device Description

Introducer 6" Length

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 Unsafe
• Direct Marking Exempt: Yes
• 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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	882.5880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44063	Neurosurgical procedure kit, non-medicated, single-use	A collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00818225020501	GS1

Premarket Submissions

Submission Number	Supplement Number
K180981	000

Device Sizes

Type	Value	Unit	Text
Length	6	Inch
Length	15.24	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 140 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -29 – 60 Degrees Celsius