Duns Number:883094039
Device Description: Carbon Tissue Marker System with Enhanced Visibility, kV
Catalog Number
040122
Brand Name
BiomarC®
Version/Model Number
040122
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 11, 2017
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
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
-
Product Code
NEU
Product Code Name
Marker, Radiographic, Implantable
Public Device Record Key
16b21725-0121-432f-9e3a-a62ede977be0
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 24, 2015
Package DI Number
10858015005179
Quantity per Package
3
Contains DI Package
00858015005172
Package Discontinue Date
December 11, 2017
Package Status
Not in Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |
| 3 | A medical device with high risk that requires premarket approval | 2 |