Premier - RING PESSARY-SUPPORT #8 - PREMIER DENTAL PRODUCTS COMPANY

Duns Number:014789663

Device Description: RING PESSARY-SUPPORT #8

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More Product Details

Catalog Number

-

Brand Name

Premier

Version/Model Number

1040108

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

K031463

Product Code Details

Product Code

HHW

Product Code Name

Pessary, Vaginal

Device Record Status

Public Device Record Key

b36e5bf5-8645-40b1-bdfe-c20d3f4f6ce3

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