Encore System

GUDID 00862211000206

Implants and delivery tools for hyoid and tongue suspension.

Siesta Medical

Sleep apnoea tongue implant, non-bioabsorbable

• Primary Device ID: 00862211000206
• NIH Device Record Key: 5ba93e0f-9df4-4142-a84c-cd29ee791fee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Encore System
• Version Model Number: FG0002
• Company DUNS: 940968808
• Company Name: Siesta Medical
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862211000206 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133680

FDA Product Code

• ORY: Prelude Tongue Suspension System

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: 2015-12-07

Devices Manufactured by Siesta Medical

• 00862211000213 - Revolution: 2020-02-06
• 00862211000220 - Encore Revision Kit: 2019-06-25
• 00862211000206 - Encore System: 2018-07-06Implants and delivery tools for hyoid and tongue suspension.
• 00862211000206 - Encore System: 2018-07-06 Implants and delivery tools for hyoid and tongue suspension.