Monet Curing Laser Large Glasses - Large laser protective glasses for use with the - CAO GROUP, INC.

Duns Number:102422578

Device Description: Large laser protective glasses for use with the Monet Curing Laser.

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More Product Details

Catalog Number

-

Brand Name

Monet Curing Laser Large Glasses

Version/Model Number

001-00107

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)

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

QNF

Product Code Name

Laser Activator For Polymerization

Device Record Status

Public Device Record Key

21b2ee99-a2b8-48a0-83cc-7481ea1eff75

Public Version Date

December 22, 2020

Public Version Number

1

DI Record Publish Date

December 14, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CAO GROUP, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 40
2 A medical device with a moderate to high risk that requires special controls. 51