Duns Number:312844095
Device Description: The support cushion serves as a comfortable rest on the coil housing of the Breast BI 7. T The support cushion serves as a comfortable rest on the coil housing of the Breast BI 7. The use of the support cushion ensures that the patient can lie comfortably on the coil even for several minutes, so that movement artefacts can be minimised.
Catalog Number
120177
Brand Name
Support cushion comfort Breast
Version/Model Number
01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
K162651
Product Code
MOS
Product Code Name
Coil, Magnetic Resonance, Specialty
Public Device Record Key
9f5a3f13-e9d0-416a-8703-e3b9bb2f0b28
Public Version Date
July 23, 2021
Public Version Number
1
DI Record Publish Date
July 15, 2021
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 518 |