Duns Number:486741981
Device Description: A clamp for replacement on the extraction clamp when the blade is damaged. The clamp is sy A clamp for replacement on the extraction clamp when the blade is damaged. The clamp is symmetric and therefore can be used for either side. The extraction clamp is a hand-held instrument, in combination with the slap hammer, used to extract any femoral implants, as well as any tibial implants.This is a reusable device.
Catalog Number
T16813
Brand Name
Clamp
Version/Model Number
T16813
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
HXD
Product Code Name
Clamp
Public Device Record Key
d985cf39-8394-4738-963a-d3575604b4f7
Public Version Date
September 03, 2020
Public Version Number
1
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 |