Take 1 Advanced - Impression Material - Regular Body Wash - Super - KERR CORPORATION

Duns Number:847905890

Device Description: Impression Material - Regular Body Wash - Super Fast Set - 2 Cartridges (50 ml each)

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More Product Details

Catalog Number

-

Brand Name

Take 1 Advanced

Version/Model Number

33973

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

ELW

Product Code Name

MATERIAL, IMPRESSION

Device Record Status

Public Device Record Key

fd435d30-7a49-41d7-91d2-5f595407ee23

Public Version Date

March 16, 2020

Public Version Number

4

DI Record Publish Date

August 31, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KERR CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 13
U Unclassified 1