Catalog Number

-

Brand Name

StarX-2

Version/Model Number

9380000200

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K212103

Product Code

MUH

Product Code Name

System, X-Ray, Extraoral Source, Digital

Public Device Record Key

d66d07b8-e070-4fb5-9647-5ce6c2135c2c

Public Version Date

September 10, 2021

Public Version Number

1

DI Record Publish Date

September 02, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-