SE Cushion - SE Cushion 20pk - ZIRC DENTAL PRODUCTS, INC.

Duns Number:064783913

Device Description: SE Cushion 20pk

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More Product Details

Catalog Number

-

Brand Name

SE Cushion

Version/Model Number

50Z970-360

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)

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

DYN

Product Code Name

Mouthpiece, Saliva Ejector

Device Record Status

Public Device Record Key

62e55ad6-a4f2-455a-a783-1b576435b6da

Public Version Date

October 17, 2022

Public Version Number

1

DI Record Publish Date

October 07, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZIRC DENTAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 399