Catalog Number

-

Brand Name

TubeClear

Version/Model Number

TC-0812

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K163092,K163092,K163092

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

78cde2a9-5d79-474b-b2fa-9f942ef0dce3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 02, 2017

Package DI Number

20850458007618

Quantity per Package

10

Contains DI Package

00850458007614

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton