Piccolo Composite Nailing System - Wrench for use with the Piccolo Composite Ankle - CARBOFIX ORTHOPEDICS LTD

Duns Number:649185170

Device Description: Wrench for use with the Piccolo Composite Ankle Arthrodesis Nailing System

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More Product Details

Catalog Number

PFT910390

Brand Name

Piccolo Composite Nailing System

Version/Model Number

Wrench

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

K123810

Product Code Details

Product Code

HSB

Product Code Name

Rod, Fixation, Intramedullary And Accessories

Device Record Status

Public Device Record Key

b2edd59c-c38c-4710-b021-337cd766c20c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 27, 2017

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