MedGyn Pessary Silione Donut #3 050013

GUDID M803050013

Pessary Silicone donut is used treat uterine prolapse.

MEDGYN PRODUCTS, INC.

Pelvic-organ-supporting pessary
Primary Device IDM803050013
NIH Device Record Key3dfd75c3-f3e5-4e3a-9ddb-652608fbf395
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedGyn Pessary Silione Donut #3
Version Model NumberPessary Silicone Donut #3
Catalog Number050013
Company DUNS103913430
Company NameMEDGYN PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM803050013 [Primary]

FDA Product Code

HHWPessary, Vaginal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-08
Device Publish Date2016-10-14

Devices Manufactured by MEDGYN PRODUCTS, INC.

M803019000 - MedGyn MGC-200 Cryotherapy System2024-05-08 unit, cryosurgical, accessories
M803020301 - MedGyn Disposable Amnio Hook2024-05-08 MedGyn Disposable Amnio Hook
M803LE04105 - Loop Electrodes 10X5mm2024-01-11 Loop Electrodes 10X5mm Box 20
M803LE05101 - Loop Electrodes 10x10mm2024-01-11 Loop Electrodes 10x10mm Box 20
M803LE06101 - Square Electrodes 10x10mm2024-01-11 Square Electrodes 10x10mm SQ Box 20
M803LE06108 - Square Electrodes 10x8mm 2024-01-11 Square Electrodes 10x8mm SQ Box 20
M803LE07158 - Loop Electrodes 15x8mm2024-01-11 Loop Electrodes 15x8mm Box 20
M803LE09208 - Loop Electrodes 20x8mm 2024-01-11 Loop Electrodes 20x8mm Box 20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.