Duns Number:203296434
Device Description: SteriTrak is a sterile, temporarily implantable Kirschner wire (K-wire) intended to be imp SteriTrak is a sterile, temporarily implantable Kirschner wire (K-wire) intended to be implanted into any bone for the purposes of providing an anchor for skeletal traction.
Catalog Number
-
Brand Name
Arbutus Medical
Version/Model Number
SteriTrak
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
JEC
Product Code Name
Component, Traction, Invasive
Public Device Record Key
203e2001-265a-4374-8dc6-70127b05a792
Public Version Date
October 27, 2021
Public Version Number
1
DI Record Publish Date
October 19, 2021
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |