Catalog Number

-

Brand Name

Silicone Endo Drain Kit (J Connector+Bendable Trocar)

Version/Model Number

2015-9621JB

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

-

Product Code

GCD

Product Code Name

Connector, Catheter

Public Device Record Key

48f340c9-ec6e-498a-9388-758022595ef4

Public Version Date

March 08, 2022

Public Version Number

2

DI Record Publish Date

January 07, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-