Duns Number:135057938
Device Description: SENOMARK® ULTRA Breast Tissue Marker, 12 Ga EnCor, Titanium Ribbon
Catalog Number
SMEC12R
Brand Name
SenoMark® Ultra Breast Tissue Marker
Version/Model Number
SMEC12R
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
3a9aa5b6-fcf9-4c86-9597-d25d4a012f04
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
October 02, 2015
Package DI Number
10801741032056
Quantity per Package
10
Contains DI Package
00801741032059
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 |