FemSoft® Insert Female Urethral Insert 70200

GUDID 00801741011122

Female Urethral Insert

Rochester Medical Corporation

Female-incontinence urethral balloon

• Primary Device ID: 00801741011122
• NIH Device Record Key: 6d42c164-af70-457f-af71-dace141f14a9
• Commercial Distribution Discontinuation: 2016-05-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: FemSoft® Insert Female Urethral Insert
• Version Model Number: 70200
• Catalog Number: 70200
• Company DUNS: 605440718
• Company Name: Rochester Medical Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)243-3315
• Email: medical.services@crbard.com
• Phone: +1(800)243-3315
• Email: medical.services@crbard.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741011122 [Primary]
GS1	10801741011129 [Package]; Package: Other [1 Units]; Discontinued: 2016-05-12; Not in Commercial Distribution

FDA Product Code

• OCK: Transurethral occlusion insert, urinary incontinence-control, female

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-03-27

On-Brand Devices [FemSoft® Insert Female Urethral Insert]

• 00801741011122: Female Urethral Insert
• 10801741011112: Female Urethral Insert
• 10801741011105: Female Urethral Insert
• 10801741011099: Female Urethral Insert
• 10801741011082: Female Urethral Insert
• 10801741011075: Female Urethral Insert
• 10801741011068: Female Urethral Insert