TGS

GUDID 00850002250275

Universal Headrest Adapter C

ENTELLUS MEDICAL, INC.

ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest

• Primary Device ID: 00850002250275
• NIH Device Record Key: 8cd76b95-db29-4518-a9a5-ece5df8d580c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TGS
• Version Model Number: 8000-010-011
• Company DUNS: 017283879
• Company Name: ENTELLUS MEDICAL, INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850002250275 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193502

FDA Product Code

• PGW: Ear, Nose, And Throat Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-07-07
• Device Publish Date: 2020-05-19

On-Brand Devices [TGS]

• 00850002250220: Guidewire
• 00850002250275: Universal Headrest Adapter C
• 00850002250268: Universal Headrest Adapter B
• 00850002250251: Universal Headrest Adapter A
• 00850002250244: Universal Headrest Mounting Arm
• 00850002250237: Universal Headrest