Duns Number:883094039
Device Description: Preloaded Tribell Carbon Tissue Marker - Distal Needle Tip Delivery
Catalog Number
040321
Brand Name
BiomarC®
Version/Model Number
040321
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
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
170435f4-44ff-40a7-aa7a-a687620bbaaa
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
August 11, 2017
Package DI Number
10858015005650
Quantity per Package
10
Contains DI Package
00858015005653
Package Discontinue Date
-
Package Status
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 |