XprESS ENT Dilation System ULF-206

GUDID 00857326005147

XprESS Ultra 6x8mm ENT Dilation System

ENTELLUS MEDICAL, INC.

Nasal/paranasal balloon catheter

• Primary Device ID: 00857326005147
• NIH Device Record Key: c983a217-cd78-4577-a127-1ccea5b5a071
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XprESS ENT Dilation System
• Version Model Number: MSB&LLF
• Catalog Number: ULF-206
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857326005147 [Primary]
GS1	10857326005144 [Package]; Package: Shelf Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163509

FDA Product Code

• LRC: Instrument, Ent Manual Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-06-07
• Device Publish Date: 2017-11-27

On-Brand Devices [XprESS ENT Dilation System]

• 00857326005147: XprESS Ultra 6x8mm ENT Dilation System
• 00857326005130: XprESS Ultra 5x8mm ENT Dilation System
• 00857326005123: XprESS Ultra 6x20mm ENT Dilation System
• 00857326005116: XprESS Ultra 5x20mm ENT Dilation System
• 00857326005079: XprESS Pro 6x8mm ENT Dilation System
• 00857326005062: XprESS Pro 7x18mm ENT Dilation System
• 00857326005055: XprESS Pro 6x18mm ENT Dilation System
• 00857326005048: XprESS LoProfile 6x8mm ENTDilation System
• 00857326005031: XprESS LoProfile 5x8mm ENT Dilation System
• 00857326005024: XprESS LoProfile 7x20mm ENT Dilation System
• 00857326005017: XprESS LoProfile 6x20mm ENT Dilation System
• 00857326005000: XprESS LoProfile 5x20mm ENT Dilation System