PATTERSON PDCARE - PDCARE 2.5% GLUTE QT - PATTERSON DENTAL SUPPLY, INC.

Duns Number:171843584

Device Description: PDCARE 2.5% GLUTE QT W/ACTIV                                                    

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More Product Details

Catalog Number

-

Brand Name

PATTERSON PDCARE

Version/Model Number

070877035

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

MED

Product Code Name

Sterilant, Medical Devices

Device Record Status

Public Device Record Key

356cb3ab-0e33-4f88-8daa-1f8cae325bb4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

D6620708770352

Quantity per Package

16

Contains DI Package

D6620708770350

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"PATTERSON DENTAL SUPPLY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 145
U Unclassified 9