Catalog Number

500-1036

Brand Name

Medstone

Version/Model Number

Medstone3 ERCP KIT

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

-

Product Code

IXR

Product Code Name

Table, Radiographic, Tilting

Public Device Record Key

508dd8f0-6556-406e-98be-723014f9f789

Public Version Date

January 30, 2020

Public Version Number

1

DI Record Publish Date

January 22, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-