Catalog Number

-

Brand Name

Surgimedics®

Version/Model Number

908010-000

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

Yes

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

GBZ

Product Code Name

Catheter, Cholangiography

Public Device Record Key

cca559e6-ba3e-487b-8650-8d65579b09be

Public Version Date

November 19, 2020

Public Version Number

3

DI Record Publish Date

September 23, 2017

Package DI Number

10814716020002

Quantity per Package

5

Contains DI Package

00814716020005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-