Niagara - Xi Multi Basket and tubing is used with the - MEDISAFE UK LIMITED

Duns Number:505942961

Device Description: Xi Multi Basket and tubing is used with the InnoWave Pro and PCF Pro Sonic Irrigators

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More Product Details

Catalog Number

IW1051

Brand Name

Niagara

Version/Model Number

MP21906

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MEC

Product Code Name

Disinfector, medical devices

Device Record Status

Public Device Record Key

18abfaba-53d4-4d35-8ae1-9bd00d7277a5

Public Version Date

March 26, 2021

Public Version Number

1

DI Record Publish Date

March 18, 2021

Additional Identifiers

Package DI Number

15060247265237

Quantity per Package

6

Contains DI Package

05060247265230

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"MEDISAFE UK LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 27