Navina™ Classic System Small Refill - Navina Classic Transanal Irrigation. 1 Navina - Dentsply Ih AB

Duns Number:354059073

Device Description: Navina Classic Transanal Irrigation. 1 Navina Classic control unit, 1 Water container, 1 T Navina Classic Transanal Irrigation. 1 Navina Classic control unit, 1 Water container, 1 Tube set, 2 Rectal catheters small, Non Sterile Device. Rx Only.

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More Product Details

Catalog Number

6900840

Brand Name

Navina™ Classic System Small Refill

Version/Model Number

69008

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

FCE

Product Code Name

Enema kit

Device Record Status

Public Device Record Key

5ccfc6d2-481c-4b12-bf1e-2e31c42d49ef

Public Version Date

December 25, 2019

Public Version Number

1

DI Record Publish Date

December 17, 2019

Additional Identifiers

Package DI Number

07392532243752

Quantity per Package

3

Contains DI Package

07392532243738

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CustomerPackaging

"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