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

-