Catalog Number

-

Brand Name

VIVE

Version/Model Number

INS1043

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

76c47905-426e-4a10-a029-e689bde4d43e

Public Version Date

November 06, 2020

Public Version Number

2

DI Record Publish Date

July 25, 2019

Package DI Number

10818323028505

Quantity per Package

95

Contains DI Package

00818323028508

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case