Catalog Number

-

Brand Name

Thoracic Drain

Version/Model Number

TC-xxxxx

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GBS

Product Code Name

CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY

Public Device Record Key

23a6f4f8-2478-44e6-affc-25d038e7e2ba

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

July 16, 2015

Package DI Number

10803622106054

Quantity per Package

10

Contains DI Package

00803622106057

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE