Duns Number:140727624
Device Description: V-Mark Breast Biopsy Site Marker with Titanium Achor For 12 ga Suros Vacuum Assisted Biops V-Mark Breast Biopsy Site Marker with Titanium Achor For 12 ga Suros Vacuum Assisted Biopsy System
Catalog Number
766712120SST
Brand Name
V-Mark™ Breast Biopsy Site Marker
Version/Model Number
12 ga
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
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
K053518,K053518
Product Code
NEU
Product Code Name
Marker, Radiographic, Implantable
Public Device Record Key
cb6e2f27-87c6-466d-a50f-745b46d0bd7d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 23, 2015
Package DI Number
20886333007169
Quantity per Package
10
Contains DI Package
00886333007165
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 347 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1205 |