Solesta

Basic Information

• Brand Name: Solesta
• Primary DI: 00850004725016
• Version / Model: Gel 1.0 mL Syringe
• Catalog Number: 011506
• Company Name: PALETTE LIFE SCIENCES, INC.
• Labeler DUNS: 116951700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-01
• Public Version: 2
• Public Version Date: 2023-03-02
• Public Version Status: Update
• Public Device Record Key: d081f69f-7d48-4cdd-89b9-2b87df70d8c8

Device Description

Solesta injectable gel

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	00850004725016	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P100014	021

Device Sizes

Type	Value	Unit	Text
Total Volume	1	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Protect from freezing and sunlight
• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius