Tip ClearLift QS Scanner 5x5 & CVD (Female) - ALMA LASERS LTD.

Duns Number:532283264

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

AAER05062120

Brand Name

Tip ClearLift QS Scanner 5x5 & CVD (Female)

Version/Model Number

1

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"

Yes

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

K072564

Product Code Details

Product Code

FTC

Product Code Name

Light, Ultraviolet, Dermatological

Device Record Status

Public Device Record Key

fa6985ac-28cc-438c-8ec6-e8eb6749595c

Public Version Date

January 07, 2022

Public Version Number

1

DI Record Publish Date

December 30, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALMA LASERS LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 167