Catalog Number

CRTP05-05

Brand Name

ShurFit CRT Peek Cage

Version/Model Number

CRTP05-05

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

K060132

Product Code

JDK

Product Code Name

Prosthesis, Hip, Cement Restrictor

Public Device Record Key

642cc95a-271e-4b81-b8bb-ceb8d89c34cc

Public Version Date

February 24, 2020

Public Version Number

2

DI Record Publish Date

April 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-