Pillar

GUDID 10866369000009

PILLAR PALATAL, LLC

Sleep apnoea palate implant, non-bioabsorbable Sleep apnoea palate implant, non-bioabsorbable Sleep apnoea palate implant, non-bioabsorbable Sleep apnoea palate implant, non-bioabsorbable Sleep apnoea palate implant, non-bioabsorbable Sleep apnoea palate implant, non-bioabsorbable Sleep apnoea palate implant, non-bioabsorbable Sleep apnoea palate implant, non-bioabsorbable Sleep apnoea palate implant, non-bioabsorbable Sleep apnoea palate implant, non-bioabsorbable Sleep apnoea palate implant, non-bioabsorbable Sleep apnoea palate implant, non-bioabsorbable

• Primary Device ID: 10866369000009
• NIH Device Record Key: 2a9ffb63-0cdb-4770-8ae4-be7ce121c869
• Commercial Distribution Discontinuation: 2020-01-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Pillar
• Version Model Number: PDS3000M
• Company DUNS: 079299628
• Company Name: PILLAR PALATAL, LLC
• Device Count: 6
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866369000002 [Unit of Use]
GS1	10866369000009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110623

FDA Product Code

• LRK: Device, Anti-Snoring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-03-18
• Device Publish Date: 2016-08-15