Catalog Number

TCY2

Brand Name

Tru-Close Suction Drainage System

Version/Model Number

TCY2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

April 01, 2027

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GCY

Product Code Name

Apparatus, Suction, Single Patient Use, Portable, Nonpowered

Public Device Record Key

413d000b-1ec8-4e3d-bfff-1d331aa9b5a5

Public Version Date

June 06, 2022

Public Version Number

3

DI Record Publish Date

September 11, 2017

Package DI Number

H862TCY22

Quantity per Package

5

Contains DI Package

H862TCY21

Package Discontinue Date

April 01, 2027

Package Status

In Commercial Distribution

Package Type

SHIPPER