AccessGUDID - DEVICE: Solesta® (00365649850035)

GUDID

Device Identifier (DI) Information

Brand Name: Solesta®
Version or Model: 1085003
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SALIX PHARMACEUTICALS, LTD.

Primary DI Number: 00365649850035
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 793108036 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LNM	Agent, Bulking, Injectable For Gastro-Urology Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: deb3c664-29a9-4a16-8813-38ea2ffe3bbb
Public Version Date: December 11, 2023
Public Version Number: 4
DI Record Publish Date: October 31, 2014