HySil Heavy - HySil Heavy [ 50㎖ x 4 ] Dental Impression Material - HIOSSEN, INC.

Duns Number:796083090

Device Description: HySil Heavy [ 50㎖ x 4 ] Dental Impression Material

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More Product Details

Catalog Number

-

Brand Name

HySil Heavy

Version/Model Number

ESS50H

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

ELW

Product Code Name

Material, Impression

Device Record Status

Public Device Record Key

f29d4b65-0881-44ed-8753-98f3ad58efe5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HIOSSEN, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 359
2 A medical device with a moderate to high risk that requires special controls. 1552