Monoart - Disposable, flexible saliva ejectors made of - EURONDA SPA

Duns Number:428755441

Device Description: Disposable, flexible saliva ejectors made of non-toxic, transparent PVC. Fix rounded tips. Disposable, flexible saliva ejectors made of non-toxic, transparent PVC. Fix rounded tips. Integrated metal wire. Diameter 6,5 mm. Bag of 100 pcs. Box of 5.000 pcs. Color: Lime

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More Product Details

Catalog Number

22810560

Brand Name

Monoart

Version/Model Number

MONOART® EM15 SALIVA EJECTOR

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

DYN

Product Code Name

Mouthpiece, Saliva Ejector

Device Record Status

Public Device Record Key

dd91fd5d-fd87-49ba-a585-320b3ea374ee

Public Version Date

December 11, 2019

Public Version Number

1

DI Record Publish Date

December 03, 2019

Additional Identifiers

Package DI Number

E307228105601

Quantity per Package

50

Contains DI Package

E307228105602

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