PROPEL Mini Sinus Implant with Straight Delivery System

GUDID M927600440

Intersect Ent, Inc.

Paranasal sinus spacer Paranasal sinus spacer Paranasal sinus spacer Paranasal sinus spacer Paranasal sinus spacer Paranasal sinus spacer Paranasal sinus spacer Paranasal sinus spacer Paranasal sinus spacer Paranasal sinus spacer Paranasal sinus spacer Paranasal sinus spacer Paranasal sinus spacer Paranasal sinus spacer Paranasal sinus spacer Paranasal sinus spacer Paranasal sinus spacer Paranasal sinus spacer Paranasal sinus spacer Paranasal sinus spacer Paranasal sinus spacer Paranasal sinus spacer Paranasal sinus spacer

• Primary Device ID: M927600440
• NIH Device Record Key: 34a8a7ae-30f8-4bbf-badd-3ccdfc9bd884
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROPEL Mini Sinus Implant with Straight Delivery System
• Version Model Number: 60044
• Company DUNS: 876715355
• Company Name: Intersect Ent, 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: true
• 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 Dimensions

• Stent Length: 18 Millimeter
• Maximum Stent Diameter: 42.5 Millimeter
• Stent Length: 18 Millimeter
• Maximum Stent Diameter: 42.5 Millimeter
• Stent Length: 18 Millimeter
• Maximum Stent Diameter: 42.5 Millimeter
• Stent Length: 18 Millimeter
• Maximum Stent Diameter: 42.5 Millimeter
• Stent Length: 18 Millimeter
• Maximum Stent Diameter: 42.5 Millimeter
• Stent Length: 18 Millimeter
• Maximum Stent Diameter: 42.5 Millimeter
• Stent Length: 18 Millimeter
• Maximum Stent Diameter: 42.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M927600440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P100044

FDA Product Code

• OWO: Drug-Eluting Sinus Stent

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-03-17
• Device Publish Date: 2020-10-26

Devices Manufactured by Intersect Ent, Inc.

• M927700110 - Propel: 2022-03-17
• M927500110 - Propel Contour: 2022-03-17
• M927600110 - Propel Mini: 2022-03-17
• M927600440 - PROPEL Mini Sinus Implant with Straight Delivery System: 2022-03-17
• M927600440 - PROPEL Mini Sinus Implant with Straight Delivery System: 2022-03-17