Opal Seal - Opal Seal Tips 20 Pack - ULTRADENT PRODUCTS, INC.

Duns Number:013369913

Device Description: Opal Seal Tips 20 Pack

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More Product Details

Catalog Number

500064-

Brand Name

Opal Seal

Version/Model Number

500064-

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

KXR

Product Code Name

APPLICATOR, RESIN

Device Record Status

Public Device Record Key

f6d3d540-584a-4982-aa40-6d1a69817fa4

Public Version Date

October 01, 2018

Public Version Number

1

DI Record Publish Date

August 31, 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