Premier - CUBE PESSARY W/O DRAINAGE HOLES #10 - PREMIER DENTAL PRODUCTS COMPANY

Duns Number:014789663

Device Description: CUBE PESSARY W/O DRAINAGE HOLES #10

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More Product Details

Catalog Number

-

Brand Name

Premier

Version/Model Number

1040421

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Conditional

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

K031463

Product Code Details

Product Code

HHW

Product Code Name

Pessary, Vaginal

Device Record Status

Public Device Record Key

5d8d41b2-ee59-4e19-8853-11dc2f9bf8d1

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PREMIER DENTAL PRODUCTS COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 130
2 A medical device with a moderate to high risk that requires special controls. 332