Duns Number:960905862
Device Description: TraceIT® Tissue Marker is a sterile, single use, product consisting of a pre-filled glass TraceIT® Tissue Marker is a sterile, single use, product consisting of a pre-filled glass syringe containing the synthetic, radiopaque cross-linked PEG hydrogel with an endcap.
Catalog Number
TH-1011
Brand Name
TraceIT Tissue Marker 1-UP
Version/Model Number
TH-1011
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"
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
-
Product Code
NEU
Product Code Name
Marker, Radiographic, Implantable
Public Device Record Key
f044b484-57ec-4eae-8451-277f6fa6508c
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
December 10, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |