Duns Number:026681280
Device Description: Biocompatible MRIaudio disposable ear-tip certified to 29dB NRR.
Catalog Number
302
Brand Name
MRIaudio Ear-Tip
Version/Model Number
302
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K180100,K180100,K180100,K180100,K180100
Product Code
LNH
Product Code Name
System, Nuclear Magnetic Resonance Imaging
Public Device Record Key
0a1c702e-c162-400f-bce8-2ac10fa036f8
Public Version Date
November 14, 2019
Public Version Number
2
DI Record Publish Date
October 05, 2018
Package DI Number
B6693501
Quantity per Package
100
Contains DI Package
B6693020
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Tub/Jar
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 14 |