Duns Number:009237140
Device Description: DS Sentinelle Breast 16CH Coil Kit, 1.5T Consists of 1CH Left and Right Lateral Coils and DS Sentinelle Breast 16CH Coil Kit, 1.5T Consists of 1CH Left and Right Lateral Coils and Medial Plug with box of 10 Sentinelle Biopsy grids and Fiducial Marker Block
Catalog Number
-
Brand Name
Sentinelle
Version/Model Number
9896-032-16541
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K213735
Product Code
MOS
Product Code Name
Coil, Magnetic Resonance, Specialty
Public Device Record Key
e3ff34e9-515c-4f3e-a3d1-3d908dc45b16
Public Version Date
October 24, 2022
Public Version Number
1
DI Record Publish Date
October 14, 2022
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 | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 650 |
| U | Unclassified | 4 |