FDA.reportPublic FDA data

EvaCare Pessary

Primary DI
08519520070007
Brand
EvaCare Pessary
Company
PERSONAL MEDICAL CORP.
Model
Ring w/ Support
Catalog number
RS
Device description
Pessary, Vaginal
Published
2016-10-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HHWPessary, Vaginal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHWPessary, VaginalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993308000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993308000MENTOR EVACARE VAGINAL PESSARIESMentor Corp.1999-12-13HHW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08519520070007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08519520070007085195200700078519520070007

GMDN Terms#

Term, Definition table
TermDefinition
Bladder-supporting pessaryA non-sterile plastic device designed for insertion into the vagina to facilitate management of female urinary incontinence and/or to reduce bladder prolapse. Otherwise known as a bladder-neck support prosthesis, it is designed in the form of a ring with two prongs at one end. The ring is intended to be placed and held in the vagina with the prongs projecting forwards on each side of the urethral opening, thereby supporting the urethra/bladder neck/bladder. This is a reusable device after appropriate cleaning.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width1.5Inch
Width1.75Inch
Width2Inch
Width2.25Inch
Width2.5Inch
Width2.75Inch
Width3Inch
Width3.25Inch
Width3.5Inch
Width3.75Inch
Width4Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(425) 497-1044info@personalmed.com

Regulatory Flags#

DUNS number
078511333
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08519520070009IVS-2Intravaginal Sensor45252016-10-18
08519520070010MEPAnal Sensor45202016-10-18
08519520070018EvaCare PessaryDish Pessary with SupportDSHS2016-12-06
08519520070025EvaCare PessaryCube Pessary with DrainCUD2016-12-06
08519520070063SenseRx -- Anal/Small Vaginal and Vaginal EMG4510C4510C2016-12-06
08519520070070IVS-2Intravaginal Sensor45252016-12-06
08519520070087MEPAnal Sensor45202016-12-06
08519520070148EvaCare PessaryGellhorn PessaryGD2016-12-06
08519520070032Personal Medical Corp2 Channel MEP Adaptor4695G2016-12-06
08519520070034Personal Medical Corp2 Channel MEP Adaptor4695G2016-10-31
08519520073347C3 Male Continence Device9103002018-08-27
08519520070001EvaCare PessaryRingR2016-10-10
08519520070049EvaCare PessaryRing w/ SupportRS2016-12-06
08519520070003SenseRx -- Anal/Small Vaginal and Vaginal EMG4510C4510C2016-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09903124199524CNTRL+ Bladder Support PessaryCntrl+ Inc.HHW2026-02-22
04719894430003BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430010BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430034BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430584BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430591BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430904BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430911BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430928BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430935BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430942BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430959BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430966BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430973BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430980BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894430997BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431000BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431017BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431024BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431031BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431048BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431055BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431062BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431079BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431086BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431093BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431109BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431116BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431123BiotequeBioteque Taiwan Ltd.HHW2024-12-06
04719894431130BiotequeBioteque Taiwan Ltd.HHW2024-12-06