Catalog Number

-

Brand Name

OPTION, WS CART NL4000

Version/Model Number

0-00132-001

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K102677

Product Code

JAK

Product Code Name

System, X-Ray, Tomography, Computed

Public Device Record Key

de03db2c-e20e-4583-8b0d-93fb1d52d0bb

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-