Catalog Number

TCS1000

Brand Name

Tru-Close Suction Drainage System

Version/Model Number

TCS1000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 01, 2026

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

bdc2d4d0-8114-449f-a53f-9db79fcb560f

Public Version Date

December 23, 2021

Public Version Number

3

DI Record Publish Date

September 11, 2017

Package DI Number

H862TCS10002

Quantity per Package

2

Contains DI Package

H862TCS10001

Package Discontinue Date

December 01, 2026

Package Status

In Commercial Distribution

Package Type

SHIPPER