Catalog Number

PPS922500

Brand Name

CarboClear Pedicle Screw System

Version/Model Number

Ball Tip Guide Wire

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

Yes

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

K173487,K173487

Product Code

NKB

Product Code Name

Thoracolumbosacral Pedicle Screw System

Public Device Record Key

11d6cf07-1cc7-4c4e-a38d-e649c8582039

Public Version Date

October 19, 2020

Public Version Number

2

DI Record Publish Date

July 24, 2018

Package DI Number

17290109338894

Quantity per Package

4

Contains DI Package

07290109338897

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-