Catalog Number

-

Brand Name

VIVE

Version/Model Number

SUP2013

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

b6b75289-107e-4c4c-9c6a-15c4d4982726

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

August 28, 2019

Package DI Number

10818323028949

Quantity per Package

10

Contains DI Package

00818323028942

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case