MedGyn Pessary Cube w/drain # 9 050075

GUDID M803050075

Cube Pessary is used treat uterine prolapse.

MEDGYN PRODUCTS, INC.

Pelvic-organ-supporting pessary
Primary Device IDM803050075
NIH Device Record Key970aec79-b6da-4b15-ba64-4af6e64cccab
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedGyn Pessary Cube w/drain # 9
Version Model NumberPessary Cube w/drain # 9
Catalog Number050075
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
HIBCCM803050075 [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

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