INTERSTIM®

Basic Information

• Brand Name: INTERSTIM®
• Primary DI: 20613994926306
• Version / Model: 041826
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 796986144
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2014-09-23
• Public Version: 4
• Public Version Date: 2022-12-23
• Public Version Status: Update
• Public Device Record Key: f43ad314-87ed-47f4-874f-0e088170178f
• Distribution End Date: 2022-10-25

Device Description

GROUND PAD 041826 GLOBAL FLEX

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EZW	Stimulator, electrical, implantable, for incontinence	Gastroenterology, Urology	876.5270	3
QON	Implanted electrical device intended for treatment of fecal incontinence	Gastroenterology, Urology	876.5270	3

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	20613994926306	GS1
Unit of Use	00613994926302	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P080025	046
P970004	150

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -30 – 135 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -34 – 57 Degrees Celsius