PERFECTO - PERFECTO CAD-CAM FAST SET CARTRIDGE - CROWN DELTA CORPORATION

Duns Number:030479000

Device Description: PERFECTO CAD-CAM FAST SET CARTRIDGE

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More Product Details

Catalog Number

DW99

Brand Name

PERFECTO

Version/Model Number

DW99

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

3560fcd8-e920-41d0-b2ca-30d279fcfc22

Public Version Date

May 28, 2018

Public Version Number

1

DI Record Publish Date

April 25, 2018

Additional Identifiers

Package DI Number

10818524020315

Quantity per Package

2

Contains DI Package

00818524020318

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

KIT

"CROWN DELTA CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 46