IMPRESS-RITE - M&S DENTAL IMPRESS-RITE SHM HEAVY BODY REGULAR - CROWN DELTA CORPORATION

Duns Number:030479000

Device Description: M&S DENTAL IMPRESS-RITE SHM HEAVY BODY REGULAR SET TUBE KIT

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More Product Details

Catalog Number

IMP-9007T

Brand Name

IMPRESS-RITE

Version/Model Number

IMP-9007T

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

efb59388-bcdf-4eb4-a5a8-e77fbca28d00

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 05, 2017

Additional Identifiers

Package DI Number

10818524020384

Quantity per Package

10

Contains DI Package

00818524020387

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"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