Duns Number:486741981
Device Description: A hammer with a mobile mass can be attached to the extraction clamp, as well as on the hoo A hammer with a mobile mass can be attached to the extraction clamp, as well as on the hook. It permits to give the necessary impact to extract the knee implants. This is a reusable device.
Catalog Number
T14585
Brand Name
Slap hammer
Version/Model Number
T14585
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
HXL
Product Code Name
Mallet
Public Device Record Key
b012328b-3927-49dd-ae86-998603d840f4
Public Version Date
September 02, 2020
Public Version Number
1
DI Record Publish Date
August 25, 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 |