FDA.reportPublic FDA data

EvaCare

Primary DI
00851952007636
Brand
EvaCare
Company
PERSONAL MEDICAL CORP.
Model
RK2.50 #3
Device description
#3 Ring Pessary with Knob 2.50" The EvaCare ring pessary with knob has an indication for mixed Prolapse and SUI combined and has two notches to allow for the pessary to be easily folded.
Published
2026-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00851952007636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851952007636008519520076368519520076360851952007636

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic-organ-supporting pessaryA device made of rubber or soft plastics designed for insertion into the vagina to hold the uterus, bladder and/or rectum in place and help prevent prolapse (falling or sliding of the organ from its normal position into the pelvic cavity), either as a permanent or temporary treatment; it is not dedicated to bladder-only support. It is available in a variety of shapes (e.g., rings, stems) and sizes; it may be fitted for each woman individually. This is a reusable device after appropriate cleaning.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width0

Regulatory Flags#

DUNS number
078511333
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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