Duns Number:486741981
Device Description: A hand-held instrument used to, as soon as the femoral implant has been loosed by the chis A hand-held instrument used to, as soon as the femoral implant has been loosed by the chisel blade, for punching out the femoral implant. The extremity is applied proximal onto onto the femoral anterior flange for a stable and safe extraction.This is a reusable device.
Catalog Number
T14586
Brand Name
Puncher
Version/Model Number
T14586
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LXH
Product Code Name
Orthopedic Manual Surgical Instrument
Public Device Record Key
562b0167-650c-45bd-974e-fdc5da5714ee
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
August 26, 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 | 299 |