TGS

Basic Information

• Brand Name: TGS
• Primary DI: 00850002250237
• Version / Model: 8000-010-007
• Company Name: ENTELLUS MEDICAL, INC.
• Labeler DUNS: 017283879
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-19
• Public Version: 2
• Public Version Date: 2023-07-07
• Public Version Status: Update
• Public Device Record Key: 37817bfb-e5d8-4c1b-8dd4-18e6b1dc2348

Device Description

Universal Headrest

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31920	ENT headrest	A device designed to be attached to an appropriate operating table to support and stabilize the head of a recumbent patient during an ear/nose/throat (ENT) procedure. The headrest is typically made of metal and synthetic materials that incorporate a cup-shaped, or indented with a central hole, cushion or pad that provides a softer surface for the patient's head to rest in. It is available in various shapes and sizes and will typically include mechanical mechanisms that enable adjustments in relation to the table top. This is a reusable device after appropriate cleaning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850002250237	GS1

Premarket Submissions

Submission Number	Supplement Number
K193502	000