Piccolo Composite Plate System - Forceps for use with the Piccolo Composite Distal - CARBOFIX ORTHOPEDICS LTD

Duns Number:649185170

Device Description: Forceps for use with the Piccolo Composite Distal Femur and Diaphyseal Plate Systems

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More Product Details

Catalog Number

PL921790

Brand Name

Piccolo Composite Plate System

Version/Model Number

Forceps - Pointed Tip

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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,K143496

Product Code Details

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Device Record Status

Public Device Record Key

0a6d93d8-acb5-4c57-b11f-a46dc9555968

Public Version Date

January 11, 2021

Public Version Number

7

DI Record Publish Date

September 18, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARBOFIX ORTHOPEDICS LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1387