Catalog Number

-

Brand Name

NC1S80SE-YM

Version/Model Number

NC1S80SE-YM

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

K082710,K082710

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

21989a31-a337-4212-9a62-2ec7b0bad33a

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

March 01, 2019

Package DI Number

20816336022036

Quantity per Package

10

Contains DI Package

10816336022039

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-