Catalog Number

DTJ019

Brand Name

CRF II - RADIAL PROSTHESIS

Version/Model Number

DTJ019

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"

Yes

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

-

Product Code

JDB

Product Code Name

PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Public Device Record Key

206b73ba-ed95-49e3-baeb-9ac6c6dfce6e

Public Version Date

March 24, 2022

Public Version Number

4

DI Record Publish Date

October 16, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-