Duns Number:536935331
Device Description: The pack contains five radel K-FIX® ergonomically profiled pin protectors that has three m The pack contains five radel K-FIX® ergonomically profiled pin protectors that has three main functions in foot surgery for protruding wires.It protects patients and/or hospital staff from wire sharp ends.It prevents any inward pin migration as well as reducing bandage size.It allows easy removal of the wire by the surgeon.Its fixation requires no instrument. The protector ball is introduced until firm locking on the wire extremity previously bent.
Catalog Number
-
Brand Name
K-FIX®
Version/Model Number
119050ND
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
K022597,K022597
Product Code
HTY
Product Code Name
PIN, FIXATION, SMOOTH
Public Device Record Key
a8da6ddf-7fac-486f-b2b6-b6cfe006bc9d
Public Version Date
December 15, 2020
Public Version Number
2
DI Record Publish Date
November 23, 2020
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 | 388 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 235 |