EvaCare Pessary

Basic Information

• Brand Name: EvaCare Pessary
• Primary DI: 08519520070001
• Version / Model: Ring
• Catalog Number: R
• Company Name: PERSONAL MEDICAL CORP.
• Labeler DUNS: 078511333
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-10
• Public Version: 4
• Public Version Date: 2020-12-31
• Public Version Status: Update
• Public Device Record Key: 5564c775-b450-4eac-abe0-4919430b4f00
• Distribution End Date: 2020-12-31

Device Description

Pessary, Vaginal

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HHW	Pessary, Vaginal	Obstetrics/Gynecology	884.3575	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59167	Bladder-supporting pessary	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08519520070001	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K993308	000

Device Sizes

Type	Value	Unit	Text
Width	4.00	Inch
Width	3.75	Inch
Width	3.50	Inch
Width	3.25	Inch
Width	3.00	Inch
Width	2.75	Inch
Width	2.50	Inch
Width	2.25	Inch
Width	2.00	Inch
Width	1.75	Inch
Width	1.50	Inch