Duns Number:036985604
Device Description: The TenZor Carbon Fiber Traction Unit Assembly is lightweight and tension adjustable. The The TenZor Carbon Fiber Traction Unit Assembly is lightweight and tension adjustable. The unit attaches to the Abductor Bars of Orthopedic Tables by means of a Traction Accessory clamp to hold Foot Traction boot and Pad (included) in place to pull Traction.
Catalog Number
BF72
Brand Name
TenZor
Version/Model Number
BF72
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HST
Product Code Name
Apparatus, traction, non-powered
Public Device Record Key
f04a943b-7b4e-4633-a5c9-cb016e4453e0
Public Version Date
May 03, 2021
Public Version Number
1
DI Record Publish Date
April 23, 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 | 1528 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1557 |