Navina™ Smart App for Android - Navina Smart Transanal Irrigation. Bowel diary APP - Dentsply Ih AB

Duns Number:354059073

Device Description: Navina Smart Transanal Irrigation. Bowel diary APP

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More Product Details

Catalog Number

75751

Brand Name

Navina™ Smart App for Android

Version/Model Number

75751

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

OUG

Product Code Name

Medical device data system

Device Record Status

Public Device Record Key

9620c789-87e3-466f-b12c-99c16b055246

Public Version Date

December 27, 2019

Public Version Number

1

DI Record Publish Date

December 19, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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