HOSE MCX-400 - Hoses and couplings are essential accessories - BIEN-AIR PORTUGAL, UNIPESSOAL, LDA

Duns Number:338234588

Device Description: Hoses and couplings are essential accessories meant to connect micro-motors to the console

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More Product Details

Catalog Number

1601081-001

Brand Name

HOSE MCX-400

Version/Model Number

1601081-001

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

-

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

EFB

Product Code Name

Handpiece, air-powered, dental

Device Record Status

Public Device Record Key

41586dfa-84cb-41fe-bbb4-0dbf9e2f3c5a

Public Version Date

October 26, 2022

Public Version Number

2

DI Record Publish Date

June 17, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIEN-AIR PORTUGAL, UNIPESSOAL, LDA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 80