Solesta®

GUDID 00365649850035

SOLESTA® is indicated for the treatment of fecal incontinence in patients 18 years and older who have failed conservative therapy (eg. diet, fiber therapy, anti-motility medications).

SALIX PHARMACEUTICALS, LTD.

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• Primary Device ID: 00365649850035
• NIH Device Record Key: deb3c664-29a9-4a16-8813-38ea2ffe3bbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solesta®
• Version Model Number: 1085003
• Company DUNS: 793108036
• Company Name: SALIX PHARMACEUTICALS, LTD.
• 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: false
• 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: 8005080024
• Email: salix@medcomsol.com
• Phone: 8005080024
• Email: salix@medcomsol.com
• Phone: 8005080024
• Email: salix@medcomsol.com
• Phone: 8005080024
• Email: salix@medcomsol.com
• Phone: 8005080024
• Email: salix@medcomsol.com
• Phone: 8005080024
• Email: salix@medcomsol.com
• Phone: 8005080024
• Email: salix@medcomsol.com
• Phone: 8005080024
• Email: salix@medcomsol.com
• Phone: 8005080024
• Email: salix@medcomsol.com
• Phone: 8005080024
• Email: salix@medcomsol.com
• Phone: 8005080024
• Email: salix@medcomsol.com
• Phone: 8005080024
• Email: salix@medcomsol.com
• Phone: 8005080024
• Email: salix@medcomsol.com
• Phone: 8005080024
• Email: salix@medcomsol.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00365649850035 [Primary]
GS1	10365649850032 [Package]; Package: Transport box [32 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P100014

FDA Product Code

• LNM: Agent, Bulking, Injectable For Gastro-Urology Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-10-31

Devices Manufactured by SALIX PHARMACEUTICALS, LTD.

• 00365649850035 - Solesta®: 2018-07-06SOLESTA® is indicated for the treatment of fecal incontinence in patients 18 years and older who have failed conservative therapy (eg. diet, fiber therapy, anti-motility medications).
• 00365649850035 - Solesta®: 2018-07-06 SOLESTA® is indicated for the treatment of fecal incontinence in patients 18 years and older who have failed conservative thera
• 00365649922039 - Deflux®: 2018-07-06 Deflux® is a bulking agent indicated for treatment of children with vesicoureteral reflux (VUR) grades II-IV.