N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00613994728531
• Version / Model: 9734470
• Company Name: MEDTRONIC NAVIGATION, INC.
• Labeler DUNS: 835233107
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-18
• Public Version: 6
• Public Version Date: 2021-09-20
• Public Version Status: Update
• Public Device Record Key: 90928355-2462-4fec-adfa-7b4e64f2a437

Device Description

STARSHIELD 9734470 DISP FLOOR FOIL 5PK

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
LNH	System, nuclear magnetic resonance imaging	Radiology	892.1000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38370	Facility radio-frequency shielding material	A radiation protection device consisting of electrically conductive materials used in conjunction with other medical devices in a medical facility to form a barrier against radio-frequency (RF) emissions and interference. This kind of material protects medical devices and/or persons from incident or stray radio-frequency fields. This group of devices includes a wide variety of materials, e.g., copper (Cu) sheeting and copper mesh. Copper sheets and copper mesh are used in walls, floors, ceiling, doors and windows for magnetic resonance imaging rooms to prevent interference with the electronics used to form and receive the radio-frequency imaging pulses.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00613994728531	GS1
Package	20613994728535	GS1	PK	5	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K032541	000