Duns Number:649185170
Device Description: Sleeve for use with the Piccolo Composite Diaphyseal Plate System
Catalog Number
PL921060
Brand Name
Piccolo Composite Plate System
Version/Model Number
Free Hand Drill Sleeve
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
K102597,K130061
Product Code
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
8f12fe92-18b7-4510-af33-fc27e8284852
Public Version Date
September 14, 2022
Public Version Number
1
DI Record Publish Date
September 06, 2022
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 |