Catalog Number

5500236

Brand Name

CS 8100SC 3D Access

Version/Model Number

CS 8100SC 3D Access

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

-

Product Code

MUH

Product Code Name

System,x-ray,extraoral source,digital

Public Device Record Key

7ecda7a1-9bdb-47f7-aa5e-b77cd17e6574

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 03, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-