Model: 0800215
DI: 04260486610605
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
No description.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
7875d0fd-d0ee-4294-a0a3-91337840e4f1
Distribution Status:
In Commercial Distribution
DUNS Number:
312688686
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
04260486610605
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 40749
Name: MRI system coil, radio-frequency
Definition:
A radio-frequency (RF) coil acts as a transmitter, receiver, or both a transmitter and receiver of RF pulses necessary for diagnostic magnetic resonance imaging (MRI) procedures. It is used to enhance image resolution by improving signal to noise characteristics. There are two main kinds of RF coils: volume coils (which surround the part of the body being imaged) and surface coils (which are placed and secured directly on or under an area of interest). This group of devices includes a variety RF coil designs and configurations including, e.g., surface coils, phased array coils, paired saddle coils, Hemholtz pair coils or bird cage coils.
FDA Product Codes
MOS
Coil, Magnetic Resonance, Specialty
Premarket Submissions
Submission Number:
K091047
Supplement Number:
000