Catalog Number

COVO46

Brand Name

COVAORTHO-NERVE

Version/Model Number

MCG 14 46 V

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

a405e634-5661-4e46-8727-efdeb8ede0ea

Public Version Date

June 19, 2020

Public Version Number

6

DI Record Publish Date

February 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-