Premier

GUDID D6911040405

CUBE PESSARY W/ DRAINAGE HOLES #5

PREMIER DENTAL PRODUCTS COMPANY

Pelvic-organ-supporting pessary
Primary Device IDD6911040405
NIH Device Record Key26fbee6d-ac6f-4cfa-81e0-24965debda8a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremier
Version Model Number1040405
Company DUNS014789663
Company NamePREMIER DENTAL PRODUCTS COMPANY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD6911040405 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HHWPessary, Vaginal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-08
Device Publish Date2016-09-16

On-Brand Devices [Premier]

00856402006344Decan Stopper Size 9 Closure Full
00856402006337Decan Stopper Size 8 Closure Full
00856402006320Decan Stopper Size 7 Closure Full
00856402006313Decan Stopper Size 6 Closure Full
00856402006306Decan Stopper Size 5 Closure Full
00856402006290Decan Stopper Size 4 Closure Full
00856402006283Decan Stopper Size 3 Closure Full
00856402006276Decan Stopper Size 2 Closure Full
00856402006269Decan Stopper Size 1 Closure Full
00856402006252Decan Stopper Size 0 Closure Full
00856402006245Decan Stopper Size 9 Closure 3/4
00856402006238Decan Stopper Size 8 Closure 3/4
00856402006221Decan Stopper Size 7 Closure 3/4
00856402006214Decan Stopper Size 6 Closure 3/4
00856402006207Decan Stopper Size 0 Closure 3/4
00856402006191Decan Stopper Size 8 Closure 1/2
00856402006184Decan Stopper Size 7 Closure 1/2
00856402006177Decan Stopper Size 6 Closure 1/2
00856402006160Decan Stopper Size 5 Closure 1/2
00856402006153Decan Stopper Size 0 Closure 1/2
00856402006146Decan Stopper Size 7 Closure 1/4
00856402006139Decan Stopper Size 6 Closure 1/4
00856402006122Decan Stopper Size 5 Closure 1/4
00856402006115Decan Stopper Size 4 Closure 1/4
00856402006108TT Air-Lon® Inhalation Set Sz 8
00856402006092TT Air-Lon® Inhalation Set Sz 7
00856402006085TT Air-Lon® Inhalation Set Sz 6
00856402006078TT Air-Lon® Inhalation Set Sz 4
00856402006061TT Air-Lon® Sz 8
00856402006054TT Air-Lon® Sz 7
00856402006047TT Air-Lon® Sz 6
00856402006030TT Air-Lon® Sz 5
00856402006016TT Air-Lon® Sz 4
D6913001470NEXTEMP CEMENT BULK KIT
D6911040600PESSARY FITTING SET (6)
D6911040421CUBE PESSARY W/O DRAINAGE HOLES #10
D6911040420CUBE PESSARY W/ DRAINAGE HOLES #10
D6911040419CUBE PESSARY W/O DRAINAGE HOLES #9
D6911040418CUBE PESSARY W/O DRAINAGE HOLES #8
D6911040417CUBE PESSARY W/O DRAINAGE HOLES #7
D6911040416CUBE PESSARY W/O DRAINAGE HOLES #6
D6911040415CUBE PESSARY W/O DRAINAGE HOLES #5
D6911040414CUBE PESSARY W/O DRAINAGE HOLES #4
D6911040413CUBE PESSARY W/O DRAINAGE HOLES #3
D6911040412CUBE PESSARY W/O DRAINAGE HOLES #2
D6911040411CUBE PESSARY W/O DRAINAGE HOLES #1
D6911040410CUBE PESSARY W/O DRAINAGE HOLES #0
D6911040409CUBE PESSARY W/ DRAINAGE HOLES #9
D6911040408CUBE PESSARY W/ DRAINAGE HOLES #8
D6911040407CUBE PESSARY W/ DRAINAGE HOLES #7

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2021-01-13

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