Catalog Number

-

Brand Name

VIVE

Version/Model Number

INS1015

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OHI

Product Code Name

Orthosis, Foot Drop

Public Device Record Key

e19536d1-ab2c-47c3-9a8b-18173de0dc6d

Public Version Date

March 01, 2019

Public Version Number

1

DI Record Publish Date

January 29, 2019

Package DI Number

10818323026068

Quantity per Package

102

Contains DI Package

00818323026061

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case