IMPRESS-RITE HP MIXING TIPS - M&S DENTAL IMPRESS-RITE HP MIXING TIPS (PURPLE - - CROWN DELTA CORPORATION

Duns Number:030479000

Device Description: M&S DENTAL IMPRESS-RITE HP MIXING TIPS (PURPLE - 7.5MM) 48/BAG

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More Product Details

Catalog Number

VPS-8120

Brand Name

IMPRESS-RITE HP MIXING TIPS

Version/Model Number

VPS-8120

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

Yes

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

EID

Product Code Name

Syringe, Restorative And Impression Material

Device Record Status

Public Device Record Key

163355be-cbf7-40e2-b08f-9fabf713626d

Public Version Date

October 15, 2019

Public Version Number

1

DI Record Publish Date

October 07, 2019

Additional Identifiers

Package DI Number

10818524020544

Quantity per Package

48

Contains DI Package

00818524020547

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BAG

"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