Maxso S20A-NS - S20A-NS, Straight Nose Cone, 1:1, Non-Spray, - Beyes Dental Canada Inc

Duns Number:244261462

Device Description: S20A-NS, Straight Nose Cone, 1:1, Non-Spray, Non-Optic

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More Product Details

Catalog Number

-

Brand Name

Maxso S20A-NS

Version/Model Number

ST2010

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)

-

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

cdb97a29-2c44-4281-8025-9476c55ef6ea

Public Version Date

April 22, 2019

Public Version Number

1

DI Record Publish Date

April 12, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BEYES DENTAL CANADA INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 150
2 A medical device with a moderate to high risk that requires special controls. 17
U Unclassified 6