Duns Number:026681280
Device Description: MRI-safe ear inserts with stethoscope style headset; provides patients with 29dB hearing p MRI-safe ear inserts with stethoscope style headset; provides patients with 29dB hearing protection and allows patients to listen to audio entertainment. Standard two prong pneumatic headphone connection. Designed for use with MRIaudio Ear-tips.
Catalog Number
320
Brand Name
Wishbone Headset
Version/Model Number
320
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
-
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
Product Code
LNH
Product Code Name
System, Nuclear Magnetic Resonance Imaging
Public Device Record Key
5f02181d-9184-4cab-bf66-f679c4d1cd3b
Public Version Date
November 14, 2019
Public Version Number
2
DI Record Publish Date
October 05, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |