AccessGUDID - DEVICE: EvaCare Pessary (08519520070001)

GUDID

Device Identifier (DI) Information

Brand Name: EvaCare Pessary
Version or Model: Ring
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: R
Company Name: PERSONAL MEDICAL CORP.

Primary DI Number: 08519520070001
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 078511333 *Terms of Use

Device Description: Pessary, Vaginal

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HHW	Pessary, Vaginal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K993308	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type 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

Device Record Status

Public Device Record Key: 5564c775-b450-4eac-abe0-4919430b4f00
Public Version Date: December 31, 2020
Public Version Number: 4
DI Record Publish Date: October 10, 2016