UniCore - UniCore Post Size #2 25pk - ULTRADENT PRODUCTS, INC.

Duns Number:013369913

Device Description: UniCore Post Size #2 25pk

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More Product Details

Catalog Number

4097

Brand Name

UniCore

Version/Model Number

4097

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

ELR

Product Code Name

POST, ROOT CANAL

Device Record Status

Public Device Record Key

734f9a90-c030-413b-88be-7a7b4a0a8fa6

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 07, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ULTRADENT PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 450
2 A medical device with a moderate to high risk that requires special controls. 631
U Unclassified 18