UltraPro Tx - Ultrapro Tx extra Contra Disposable Prophy Angles - ULTRADENT PRODUCTS, INC.

Duns Number:013369913

Device Description: Ultrapro Tx extra Contra Disposable Prophy Angles Soft 144 pack

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More Product Details

Catalog Number

8344

Brand Name

UltraPro Tx

Version/Model Number

8344

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"

Yes

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

EHK

Product Code Name

CUP, PROPHYLAXIS

Device Record Status

Public Device Record Key

00acd9f7-8ff1-4fe5-9f20-26448a5b8681

Public Version Date

August 31, 2018

Public Version Number

1

DI Record Publish Date

July 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