Catalog Number

-

Brand Name

CA1000

Version/Model Number

2.0 SP 14

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K063628

Product Code

LLZ

Product Code Name

System, image processing, radiological

Public Device Record Key

537dcd2d-66e3-4780-ad40-05a056e10ece

Public Version Date

February 04, 2020

Public Version Number

6

DI Record Publish Date

October 18, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-