Duns Number:649185170
Device Description: Mallet for use with the Piccolo Composite Humeral, Tibial, Femoral,Proximal Femur and Ankl Mallet for use with the Piccolo Composite Humeral, Tibial, Femoral,Proximal Femur and Ankle Arthrodesis Nailing Systems, and with the CarboClear Pedicle Screw System.
Catalog Number
Q9105110
Brand Name
Piccolo Composite Nailing System / CarboClear Pedicle Screw System
Version/Model Number
Mallet
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
K173487,K091425,K100497,K102369,K111056,K123810,K151010,K153536
Product Code
HSB
Product Code Name
Rod, Fixation, Intramedullary And Accessories
Public Device Record Key
91e90bf1-1a96-4fcd-a4f7-dba8a09e2f4f
Public Version Date
October 19, 2020
Public Version Number
5
DI Record Publish Date
September 18, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1387 |