Catalog Number

-

Brand Name

Vive

Version/Model Number

SUP1069GRY

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

ILH

Product Code Name

Splint, Hand, And Components

Public Device Record Key

fdcbec87-5c32-4294-af44-e82cfef7381f

Public Version Date

March 25, 2019

Public Version Number

1

DI Record Publish Date

March 15, 2019

Package DI Number

10818323021582

Quantity per Package

40

Contains DI Package

00818323021585

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case