EvaCare Pessary CUD

GUDID 08519520070025

Pessary, Vaginal. Cube pessary is designed for third degree prolapse, cystocele and rectocele.

PERSONAL MEDICAL CORP.

Bladder-supporting pessary

Primary Device ID	08519520070025
NIH Device Record Key	378b34bb-f4c5-45fd-bd5c-a9f4922ea414
Commercial Distribution Discontinuation	2025-12-31
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	EvaCare Pessary
Version Model Number	Cube Pessary with Drain
Catalog Number	CUD
Company DUNS	078511333
Company Name	PERSONAL MEDICAL CORP.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Width	25 Millimeter
Width	29 Millimeter
Width	33 Millimeter
Width	37 Millimeter
Width	41 Millimeter
Width	45 Millimeter
Width	50 Millimeter
Width	56 Millimeter
Width	63 Millimeter
Width	70 Millimeter
Width	75 Millimeter
Width	25 Millimeter
Width	29 Millimeter
Width	33 Millimeter
Width	37 Millimeter
Width	41 Millimeter
Width	45 Millimeter
Width	50 Millimeter
Width	56 Millimeter
Width	63 Millimeter
Width	70 Millimeter
Width	75 Millimeter
Width	25 Millimeter
Width	29 Millimeter
Width	33 Millimeter
Width	37 Millimeter
Width	41 Millimeter
Width	45 Millimeter
Width	50 Millimeter
Width	56 Millimeter
Width	63 Millimeter
Width	70 Millimeter
Width	75 Millimeter
Width	25 Millimeter
Width	29 Millimeter
Width	33 Millimeter
Width	37 Millimeter
Width	41 Millimeter
Width	45 Millimeter
Width	50 Millimeter
Width	56 Millimeter
Width	63 Millimeter
Width	70 Millimeter
Width	75 Millimeter
Width	25 Millimeter
Width	29 Millimeter
Width	33 Millimeter
Width	37 Millimeter
Width	41 Millimeter
Width	45 Millimeter
Width	50 Millimeter
Width	56 Millimeter
Width	63 Millimeter
Width	70 Millimeter
Width	75 Millimeter
Width	25 Millimeter
Width	29 Millimeter
Width	33 Millimeter
Width	37 Millimeter
Width	41 Millimeter
Width	45 Millimeter
Width	50 Millimeter
Width	56 Millimeter
Width	63 Millimeter
Width	70 Millimeter
Width	75 Millimeter
Width	25 Millimeter
Width	29 Millimeter
Width	33 Millimeter
Width	37 Millimeter
Width	41 Millimeter
Width	45 Millimeter
Width	50 Millimeter
Width	56 Millimeter
Width	63 Millimeter
Width	70 Millimeter
Width	75 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08519520070025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K993308

FDA Product Code

HHW	Pessary, Vaginal

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2025-12-31
Device Publish Date	2016-12-06

On-Brand Devices [EvaCare Pessary]

08519520070049	Pessary, Vaginal
08519520070007	Pessary, Vaginal
08519520070001	Pessary, Vaginal
08519520070148	Pessary, Vaginal. Gellhorn pessary is used for a second to third degree prolapse, or procidenti
08519520070025	Pessary, Vaginal. Cube pessary is designed for third degree prolapse, cystocele and rectocele.
08519520070018	Pessary, Vaginal. Dish Pessary is used to relieve stress incontinence and minor degrees of prol

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