Duns Number:649185170
Device Description: Screwdriver Handle for use with the Piccolo Composite Distal Fibula and One-Third Tubular Screwdriver Handle for use with the Piccolo Composite Distal Fibula and One-Third Tubular Plate Systems
Catalog Number
PL921510S
Brand Name
Piccolo Composite Plate System
Version/Model Number
Screwdriver Handle - Small
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
K120409
Product Code
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
7c579a37-1e31-4b05-9d79-38d7f820e230
Public Version Date
August 09, 2018
Public Version Number
4
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 |