Duns Number:649185170
Device Description: Screwdriver Ratchet Handle (for use with the Piccolo Composite Distal Radius Plate and Car Screwdriver Ratchet Handle (for use with the Piccolo Composite Distal Radius Plate and CarboClear Cervical Plate systems)
Catalog Number
PL921870
Brand Name
Piccolo Composite Plate System and CarboClear Cervical Plate System
Version/Model Number
Screwdriver Ratchet Handle
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,K200883
Product Code
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
34a1fda2-13b0-4b90-91b3-916b57044dc5
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1387 |