FDA.reportPublic FDA data

EvaCare Pessary

Primary DI
08519520070148
Brand
EvaCare Pessary
Company
PERSONAL MEDICAL CORP.
Model
Gellhorn Pessary
Catalog number
GD
Device description
Pessary, Vaginal. Gellhorn pessary is used for a second to third degree prolapse, or procidentia.
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
08519520070148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08519520070148085195200701488519520070148

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

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719894435893LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435909LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435916LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435923LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435930LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435947LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435954LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435961LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435978LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435985LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894435992LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436005LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436012LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436029LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436036LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436043LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436050LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436067LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436074LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436081LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436098LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436104LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436111LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436128LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436135LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436142LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436159LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436166LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436173LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24
04719894436180LTL MedicalBioteque Taiwan Ltd.HHW2026-07-24