Catalog Number

-

Brand Name

Silicone T Drainage Tube

Version/Model Number

1910-0020

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"

Yes

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

K980917,K980917

Product Code

GCA

Product Code Name

Catheter, Biliary, Surgical

Public Device Record Key

e5950653-3cd2-47b0-aa43-11a8f9dfa444

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-