Catalog Number

-

Brand Name

Innervision

Version/Model Number

27628

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 19, 2019

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K940096

Product Code

JXG

Product Code Name

Shunt, central nervous system and components

Public Device Record Key

ac2e321b-8a5f-4fbd-b602-a184223353cb

Public Version Date

October 18, 2021

Public Version Number

4

DI Record Publish Date

July 01, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-