3T Loop 11cm MR coil

Basic Information

• Brand Name: 3T Loop 11cm MR coil
• Primary DI: 04056869014357
• Version / Model: 08625662
• Company Name: Siemens Healthcare GmbH
• Labeler DUNS: 313217003
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2021-11-17
• Public Version Status: Update
• Public Device Record Key: 3bc04fb4-cdbe-4cad-8a31-ea69cd4e1b85

Device Description

MRI Coil

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• 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
LNI	System, nuclear magnetic resonance spectroscopic	Radiology	892.1000	2
OUO	Tomographic imager combining emission computed tomography with nuclear magnetic resonance	Radiology	892.1200	2
MOS	Coil, magnetic resonance, specialty	Radiology	892.1000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37654	Full-body MRI system, superconducting magnet	A diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). This system includes a superconducting magnet assembly and can be fixed-location, mobile, or transportable. Some systems can perform MR spectroscopy or various real-time imaging procedures for MRI guided interventional, therapeutic, or surgical applications. The system is available in a variety of system gantry configurations including closed bore, open bore, and open-sided or other kinds of patient accessible designs.	No	Active
58250	PET/MRI system	A diagnostic radiological imaging system that is a combination of a positron emission tomography (PET) camera system for nuclear medicine (NM) images, and a magnetic resonance imaging (MRI) system for magnetic resonance images. The nuclear medicine images and the magnetic resonance images may be registered and displayed in a fused format (overlaid in the same orientation) for the anatomical localization of the nuclear medicine data (i.e., distribution of radiopharmaceuticals). The PET and MRI portions of the system may be used independently or in combination; their images may be transferred to other systems for additional processing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04056869014357	GS1

Customer Contacts

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