Catalog Number

-

Brand Name

Standard Bougie

Version/Model Number

SB18-1

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

K191885,K191885

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

531d294a-fca8-4b85-a796-c5b97bc2cdd3

Public Version Date

May 05, 2020

Public Version Number

1

DI Record Publish Date

April 27, 2020

Package DI Number

10851677007055

Quantity per Package

8

Contains DI Package

00851677007058

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-