Catalog Number

-

Brand Name

Endowrist

Version/Model Number

480422

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

-

Product Code

NAY

Product Code Name

System, surgical, computer controlled instrument

Public Device Record Key

5c4419c5-ee59-4844-993c-3ad936051c20

Public Version Date

November 23, 2021

Public Version Number

4

DI Record Publish Date

May 04, 2018

Package DI Number

10886874115661

Quantity per Package

6

Contains DI Package

00886874115664

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX