StrataMR™

Basic Information

• Brand Name: StrataMR™
• Primary DI: 00763000067588
• Version / Model: 45910SMR
• Company Name: MEDTRONIC PS MEDICAL, INC.
• Labeler DUNS: 089055867
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-03
• Public Version: 1
• Public Version Date: 2018-12-04
• Public Version Status: New
• Public Device Record Key: 215bc956-cf3b-4ced-bfc2-c2b8b6f95121

Device Description

GUIDER SET 45910SMR ADJUST TOOL

Device Characteristics

• Single Use: No
• 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
JXG	Shunt, central nervous system and components	Neurology	882.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44856	Cerebrospinal fluid shunt valve programmer	A device intended to noninvasively modify the operating pressure of a programmable, non-active, implanted hydrocephalic valve that will be part of a hydrocephalic shunt system. It is used in neurosurgery for intra- and postoperative treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. It typically includes electronic circuits, a control panel, a programming information display, and transmitter/identification devices (e.g., smart cards). When externally placed on the location of the implanted valve, it is actuated to supply coded magnetic signals to affect mechanical changes to the pressure characteristics of the proprietary implanted valve.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00763000067588	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K181622	000