Encore System

Basic Information

• Brand Name: Encore System
• Primary DI: 00862211000206
• Version / Model: FG0002
• Company Name: Siesta Medical
• Labeler DUNS: 940968808
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-12-07
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 5ba93e0f-9df4-4142-a84c-cd29ee791fee

Device Description

Implants and delivery tools for hyoid and tongue suspension.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
ORY	Prelude Tongue Suspension System	Dental	872.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61483	Sleep apnoea tongue implant, non-bioabsorbable	A sterile device intended to be implanted into the tongue to help increase airway patency by anterior advancement and physical stabilization of the tongue in the management of obstructive sleep apnoea (OSA). It is in the form of a non-bioabsorbable looped thread implanted in the base of the tongue, attached anteriorly to the mandible with a bone anchor. Disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00862211000206	GS1

Premarket Submissions

Submission Number	Supplement Number
K133680	000