InterStim™

Basic Information

• Brand Name: InterStim™
• Primary DI: 20763000114064
• Version / Model: 041839
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 796986144
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2020-03-05
• Public Version: 1
• Public Version Date: 2020-03-13
• Public Version Status: New
• Public Device Record Key: 9a80bd17-13fb-4d08-a45c-0fdbdd7ba885

Device Description

NEEDLE 041839 FORAMN 5IN 20GA GLBL 2PK

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: Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EZW	Stimulator, electrical, implantable, for 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
Unit of Use	00763000114060	GS1
Primary	20763000114064	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P080025	187
P970004	292

Device Sizes

Type	Value	Unit	Text
Length	12.6	Centimeter