Catalog Number

E-1203SP

Brand Name

Alcor SENTINELplus

Version/Model Number

E-1203SP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 23, 2017

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

K902729

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

198e3497-4521-4447-af6d-e5f1ee1d5a87

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

March 23, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-