Duns Number:009237140
Device Description: DS Sentinelle Breast coil, Biopsy Kit 3.0T Consists of 1CH Left and Right Lateral Coils an
Catalog Number
-
Brand Name
Sentinelle
Version/Model Number
9896-032-16561
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
K213727
Product Code
MOS
Product Code Name
Coil, Magnetic Resonance, Specialty
Public Device Record Key
3fea993a-edb4-462c-9f37-956e3efd49bd
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 |