Duns Number:018925968
Catalog Number
TRIMARKTD-2S-36-12
Brand Name
TriMark
Version/Model Number
TRIMARKTD-2S-36-12
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K023450,K023450
Product Code
NEU
Product Code Name
MARKER, RADIOGRAPHIC, IMPLANTABLE
Public Device Record Key
c90a2ebe-86a1-4453-8c93-cea089b90895
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 04, 2015
Package DI Number
15420045503366
Quantity per Package
10
Contains DI Package
05420045503369
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 | 130 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 311 |
| 3 | A medical device with high risk that requires premarket approval | 96 |