Catalog Number

-

Brand Name

VIVE

Version/Model Number

SUP2026

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

ISR

Product Code Name

Band Or Belt, Pelvic Support

Public Device Record Key

91adcb91-009b-47e4-b6e8-e50e9b82d777

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

January 08, 2020

Package DI Number

10810041981018

Quantity per Package

12

Contains DI Package

00810041981011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case