Catalog Number

6901200

Brand Name

Navina™ Accessory set

Version/Model Number

69012

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"

-

For Single-Use

-

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

-

Product Code

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Public Device Record Key

7853494c-d0dd-476e-80e5-2f042997409b

Public Version Date

April 13, 2020

Public Version Number

5

DI Record Publish Date

November 10, 2017

Package DI Number

07392532179273

Quantity per Package

3

Contains DI Package

07392532179266

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Customer pack