Impression Trays - Impression Trays No. 3, Medium Upper, Blue - DYNAREX CORPORATION

Duns Number:008124539

Device Description: Impression Trays No. 3, Medium Upper, Blue

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More Product Details

Catalog Number

-

Brand Name

Impression Trays

Version/Model Number

2222

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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"

Yes

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

EHY

Product Code Name

Tray, Impression, Preformed

Device Record Status

Public Device Record Key

27b03ffd-261f-4ec9-b3f0-eb7e1feed92c

Public Version Date

September 09, 2021

Public Version Number

1

DI Record Publish Date

September 01, 2021

Additional Identifiers

Package DI Number

00616784222233

Quantity per Package

10

Contains DI Package

00616784222219

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"DYNAREX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 694
2 A medical device with a moderate to high risk that requires special controls. 226
3 A medical device with high risk that requires premarket approval 2