Home GUDID 10801741011068 FemSoft® Insert Female Urethral Insert
Primary DI 10801741011068
Brand FemSoft® Insert Female Urethral Insert
Company Rochester Medical Corporation
Model 71201
Catalog number 71201
Device description Female Urethral Insert
Published 2015-03-30
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name OCK Transurethral occlusion insert, urinary incontinence-control, female
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OCK Transurethral Occlusion Insert, Urinary Incontinence-Control, Female Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10801741011068 Package GS1 28 Not in Commercial Distribution 00801741011061 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10801741011068 10801741011068 00801741011061 00801741011061 801741011061 0801741011061
GMDN Terms# Term, Definition table Term Definition Female-incontinence urethral balloon A sterile, female urinary incontinence device (a balloon-like plug) designed to be placed into the urethral opening and inflated to occlude the urethra and prevent involuntary urination/dribbling for females who are incontinent of the bladder. It is typically made of plastic and textile materials and is designed to be inflated using an external inflation device. It is removed by the user when voiding and discarded. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 3.5 Centimeter
Regulatory Flags# DUNS number 605440718 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00801741072659 Magic3™ Hydrophilic Intermittent Catheter, Male 53614GS 53614GS 2016-09-27 00801741072666 Magic3™ Hydrophilic Intermittent Catheter, Male 53616GS 53616GS 2016-09-27 00801741011061 FemSoft® Insert Female Urethral Insert 71201 71201 2015-03-30 00801741011078 FemSoft® Insert Female Urethral Insert 71202 71202 2015-03-30 00801741011085 FemSoft® Insert Female Urethral Insert 71203 71203 2015-03-27 00801741011092 FemSoft® Insert Female Urethral Insert 72201 72201 2015-03-27 00801741011108 FemSoft® Insert Female Urethral Insert 72202 72202 2015-03-27 00801741011115 FemSoft® Insert Female Urethral Insert 72203 72203 2015-03-30 00801741072598 Magic3™ Antibacterial Hydrophilic Intermittent Catheter, Female 51514S 51514S 2016-09-26 00801741072697 Magic3™ Antibacterial Hydrophilic Intermittent Catheter, Male 53512GS 53512GS 2016-09-27 00801741072703 Magic3™ Antibacterial Hydrophilic Intermittent Catheter, Male 53514GS 53514GS 2016-09-27 10801741011075 FemSoft® Insert Female Urethral Insert 71202 71202 2015-03-30 10801741011082 FemSoft® Insert Female Urethral Insert 71203 71203 2015-03-27 10801741011099 FemSoft® Insert Female Urethral Insert 72201 72201 2015-03-27 10801741011105 FemSoft® Insert Female Urethral Insert 72202 72202 2015-03-27 10801741011112 FemSoft® Insert Female Urethral Insert 72203 72203 2015-03-30 00801741011122 FemSoft® Insert Female Urethral Insert 70200 70200 2015-03-27 10801741072496 Magic3™ Hydrophilic Intermittent Catheter, Female 51614S 51614S 2016-09-26 10801741072595 Magic3™ Antibacterial Hydrophilic Intermittent Catheter, Female 51514S 51514S 2016-09-26 10801741072656 Magic3™ Hydrophilic Intermittent Catheter, Male 53614GS 53614GS 2016-09-27
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00801741011061 FemSoft® Insert Female Urethral Insert Rochester Medical Corporation OCK 2015-03-30 00801741011078 FemSoft® Insert Female Urethral Insert Rochester Medical Corporation OCK 2015-03-30 00801741011115 FemSoft® Insert Female Urethral Insert Rochester Medical Corporation OCK 2015-03-30 10801741011075 FemSoft® Insert Female Urethral Insert Rochester Medical Corporation OCK 2015-03-30 10801741011112 FemSoft® Insert Female Urethral Insert Rochester Medical Corporation OCK 2015-03-30 00801741011085 FemSoft® Insert Female Urethral Insert Rochester Medical Corporation OCK 2015-03-27 00801741011092 FemSoft® Insert Female Urethral Insert Rochester Medical Corporation OCK 2015-03-27 00801741011108 FemSoft® Insert Female Urethral Insert Rochester Medical Corporation OCK 2015-03-27 10801741011082 FemSoft® Insert Female Urethral Insert Rochester Medical Corporation OCK 2015-03-27 10801741011099 FemSoft® Insert Female Urethral Insert Rochester Medical Corporation OCK 2015-03-27 10801741011105 FemSoft® Insert Female Urethral Insert Rochester Medical Corporation OCK 2015-03-27 00801741011122 FemSoft® Insert Female Urethral Insert Rochester Medical Corporation OCK 2015-03-27
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