TGS

GUDID 00850002250237

Universal Headrest

ENTELLUS MEDICAL, INC.

ENT headrest

• Primary Device ID: 00850002250237
• NIH Device Record Key: 37817bfb-e5d8-4c1b-8dd4-18e6b1dc2348
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TGS
• Version Model Number: 8000-010-007
• 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	00850002250237 [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