Catalog Number

COUS12

Brand Name

COVA ORTHO NERVE

Version/Model Number

MCG 11 12 AD

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 21, 2019

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

K103081

Product Code

JXI

Product Code Name

Cuff, Nerve

Public Device Record Key

fb4f1bb0-ecdb-4383-aab3-8c189fa6c00e

Public Version Date

June 19, 2020

Public Version Number

6

DI Record Publish Date

November 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-