Duns Number:135057938
Device Description: SENOMARK® ULTRA Breast Tissue Marker, 9 Ga Eviva, BioDur Coil
Catalog Number
SMEV9C
Brand Name
SenoMark® Ultra Breast Tissue Marker
Version/Model Number
SMEV9C
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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"
Yes
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
K123911,K123911
Product Code
NEU
Product Code Name
MARKER, RADIOGRAPHIC, IMPLANTABLE
Public Device Record Key
3dababd7-1ff9-4f3c-82a0-99ced11d8a6d
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
October 02, 2015
Package DI Number
10801741032124
Quantity per Package
10
Contains DI Package
00801741032127
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2835 |
| 3 | A medical device with high risk that requires premarket approval | 190 |