FDA.reportPublic FDA data

EvaCare Pessary

Primary DI
08519520070025
Brand
EvaCare Pessary
Company
PERSONAL MEDICAL CORP.
Model
Cube Pessary with Drain
Catalog number
CUD
Device description
Pessary, Vaginal. Cube pessary is designed for third degree prolapse, cystocele and rectocele.
Published
2016-12-06
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
08519520070025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08519520070025085195200700258519520070025

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
Width25Millimeter
Width29Millimeter
Width33Millimeter
Width37Millimeter
Width41Millimeter
Width45Millimeter
Width50Millimeter
Width56Millimeter
Width63Millimeter
Width70Millimeter
Width75Millimeter

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
00850073946008EvaCareG250D #42026-07-14
00850073946015EvaCareG275D #52026-07-14
00850073946022EvaCareG300D #62026-07-14
00850073946039EvaCareG325D #72026-07-14
00850073946046EvaCareG350D #82026-07-14
00850073946053EvaCareG375D #92026-07-14
00850073946060EvaCareG150SHD #02026-07-14
00850073946077EvaCareG175SHD #12026-07-14
00850073946084EvaCareG200SHD #22026-07-14
00850073946091EvaCareG225SHD #32026-07-14
00850073946107EvaCareG250SHD #42026-07-14
00850073946114EvaCareG275SHD #52026-07-14
00850073946121EvaCareG300SHD #62026-07-14
00850073946138EvaCareG325SHD #72026-07-14
00850073946145EvaCareG350SHD #82026-07-14
00850073946152EvaCareG375SHD #92026-07-14
00850073946169EvaCareCU25 #02026-07-14
00850073946176EvaCareCU29 #12026-07-14
00850073946183EvaCareCU33 #22026-07-14
00850073946190EvaCareCU37 #32026-07-14

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Primary DI, Brand, Company table
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