Catalog Number

E-500SP

Brand Name

Alcor SENTINELplus

Version/Model Number

E-500SP

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

K902641

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

1eda16f9-b2e3-439c-a372-7cf99bfb5316

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

-