Navina™ Classic control unit - Navina Classic Transanal Irrigation. 1 Navina - Dentsply Ih AB

Duns Number:354059073

Device Description: Navina Classic Transanal Irrigation. 1 Navina Classic control unit. Non Sterile Device. Rx Navina Classic Transanal Irrigation. 1 Navina Classic control unit. Non Sterile Device. Rx Only.

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More Product Details

Catalog Number

6901340

Brand Name

Navina™ Classic control unit

Version/Model Number

69013

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Device Record Status

Public Device Record Key

28cc4b01-5487-4654-ab83-abe7893b7bcc

Public Version Date

April 13, 2020

Public Version Number

4

DI Record Publish Date

November 10, 2017

Additional Identifiers

Package DI Number

07392532198533

Quantity per Package

3

Contains DI Package

07392532198526

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Customer pack

"DENTSPLY IH AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 71