Solesta®

Basic Information

• Brand Name: Solesta®
• Primary DI: 00365649850035
• Version / Model: 1085003
• Company Name: SALIX PHARMACEUTICALS, LTD.
• Labeler DUNS: 793108036
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-10-31
• Public Version: 4
• Public Version Date: 2023-12-11
• Public Version Status: Update
• Public Device Record Key: deb3c664-29a9-4a16-8813-38ea2ffe3bbb

Device Description

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).

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
LNM	Agent, Bulking, Injectable For Gastro-Urology Use	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60701	Anal tissue reconstructive material	A sterile, bioabsorbable substance intended for submucosal injection in the anal canal to add volume by serving as a space-occupying supplement (bulking agent) to the intercellular matrix of connective tissue in the treatment of faecal incontinence; it does not include a local anaesthetic agent. It is in the form of a gel of biosynthesized dextranomer microspheres and hyaluronic acid (HA) derived from bacteria. The material is typically preloaded in a disposable syringe. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00365649850035	GS1
Package	10365649850032	GS1	Transport box	32	In Commercial Distribution

Customer Contacts

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