Catalog Number

-

Brand Name

Vive

Version/Model Number

SUP1080M

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

IQE

Product Code Name

Orthosis, Lumbar

Public Device Record Key

483e9d7c-ca8c-4033-8db0-45efe3844456

Public Version Date

March 25, 2019

Public Version Number

1

DI Record Publish Date

March 15, 2019

Package DI Number

10818323022114

Quantity per Package

20

Contains DI Package

00818323022117

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case