Duns Number:203296434
Device Description: The TrakPak surgical kit is intended to provide general medical devices and an antiseptic The TrakPak surgical kit is intended to provide general medical devices and an antiseptic skin swab for the purpose of skeletal traction for a patient with a broken pelvis or lower limb.
Catalog Number
-
Brand Name
Arbutus Medical
Version/Model Number
TrakPak
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PYB
Product Code Name
Minor Surgical Procedures Tray
Public Device Record Key
956a2dcc-dc84-4a11-8806-366fb1b9b2b5
Public Version Date
June 17, 2022
Public Version Number
2
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 |