Catalog Number

-

Brand Name

VIVE

Version/Model Number

SUP1035M

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

IPG

Product Code Name

Shoe, Cast

Public Device Record Key

16d27b58-f18c-4e95-b24b-604849994cb4

Public Version Date

March 20, 2019

Public Version Number

1

DI Record Publish Date

March 12, 2019

Package DI Number

10818323027119

Quantity per Package

24

Contains DI Package

00818323027112

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case