Catalog Number

MUH-600-S45S-WW

Brand Name

Ascension® First Choice® DRUJ System

Version/Model Number

MUH600S45SWW

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

K112481

Product Code

KXE

Product Code Name

PROSTHESIS, WRIST, HEMI-, ULNAR

Public Device Record Key

fd18b0b3-989c-4b45-a510-265c10576cbb

Public Version Date

March 08, 2021

Public Version Number

4

DI Record Publish Date

October 09, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-