Pillar

Basic Information

• Brand Name: Pillar
• Primary DI: 10866369000009
• Version / Model: PDS3000M
• Company Name: PILLAR PALATAL, LLC
• Labeler DUNS: 079299628
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2016-08-15
• Public Version: 4
• Public Version Date: 2021-03-18
• Public Version Status: Update
• Public Device Record Key: 2a9ffb63-0cdb-4770-8ae4-be7ce121c869
• Distribution End Date: 2020-01-26

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
LRK	Device, Anti-Snoring	Dental	872.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61437	Sleep apnoea palate implant, non-bioabsorbable	A sterile device intended to be implanted into the soft palate to help increase airway patency by physical stabilization of the soft palate in the management of snoring and obstructive sleep apnoea (OSA). The implant is made of one or more non-bioabsorbable synthetic polymers [e.g., polyethylene (PE)] and has a short rod-like shape. 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	10866369000009	GS1
Unit of Use	00866369000002	GS1

Premarket Submissions

Submission Number	Supplement Number
K110623	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -25 – 60 Degrees Celsius