FemSoft® Insert Female Urethral Insert

Basic Information

• Brand Name: FemSoft® Insert Female Urethral Insert
• Primary DI: 00801741011061
• Version / Model: 71201
• Catalog Number: 71201
• Company Name: Rochester Medical Corporation
• Labeler DUNS: 605440718
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-03-30
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: ad0dd887-6fac-44de-8a5f-fad727bfccd3
• Distribution End Date: 2016-05-12

Device Description

Female Urethral Insert

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: No
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OCK	Transurethral occlusion insert, urinary incontinence-control, female	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
45333	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10801741011068	GS1	CA	28	Not in Commercial Distribution	2016-05-12
Primary	00801741011061	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	3.5	Centimeter