Catalog Number

DRUJ-S2145

Brand Name

NA

Version/Model Number

DRUJ-S2145

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 30, 2017

Issuing Agency

In HIBCC

MRI safety Status

MR Conditional

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KXE

Product Code Name

Prosthesis, Wrist, Hemi-, Ulnar

Public Device Record Key

0be0b167-d9ac-4748-99be-d216687cc8d2

Public Version Date

August 31, 2021

Public Version Number

4

DI Record Publish Date

June 02, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-