Monoart - Universal tips for surgical aspirators, - EURONDA SPA

Duns Number:428755441

Device Description: Universal tips for surgical aspirators, recommended for procedures on adults. Ergonomic, n Universal tips for surgical aspirators, recommended for procedures on adults. Ergonomic, non-slip grips and linear shape to keeps them quiet and promotes better hygiene and cleaning. They can be sterilized in autoclaves at up to 134°C. Connection diameter:16 mm. Length: 114 mm. Box of 10 pieces of the same colour. Colour: lime

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More Product Details

Catalog Number

22930006

Brand Name

Monoart

Version/Model Number

MONOART EM19

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

Prescription Use (Rx)

-

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

GEA

Product Code Name

Cannula, Surgical, General & Plastic Surgery

Device Record Status

Public Device Record Key

4cdd3347-c5ef-4c69-a1b6-4a96b23fe8bb

Public Version Date

December 16, 2019

Public Version Number

1

DI Record Publish Date

December 06, 2019

Additional Identifiers

Package DI Number

E307229300062

Quantity per Package

10

Contains DI Package

E307229300061

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton

"EURONDA SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 126
2 A medical device with a moderate to high risk that requires special controls. 12