Catalog Number

-

Brand Name

ViveSole

Version/Model Number

INS1050

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2022

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

ed624405-566d-4f28-aa43-b8c99c39001f

Public Version Date

June 30, 2022

Public Version Number

2

DI Record Publish Date

March 11, 2022

Package DI Number

10810041989311

Quantity per Package

144

Contains DI Package

00081004198931

Package Discontinue Date

June 30, 2022

Package Status

Not in Commercial Distribution

Package Type

Case