Propel Contour

GUDID M927500110

Intersect Ent, Inc.

Paranasal sinus spacer

• Primary Device ID: M927500110
• NIH Device Record Key: f3f1035c-f190-4611-a029-f053e7d82fd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Propel Contour
• Version Model Number: 50011
• 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: 8 Millimeter
• Maximum Stent Diameter: 27 Millimeter
• Stent Length: 8 Millimeter
• Maximum Stent Diameter: 27 Millimeter
• Stent Length: 8 Millimeter
• Maximum Stent Diameter: 27 Millimeter
• Stent Length: 8 Millimeter
• Maximum Stent Diameter: 27 Millimeter
• Stent Length: 8 Millimeter
• Maximum Stent Diameter: 27 Millimeter
• Stent Length: 8 Millimeter
• Maximum Stent Diameter: 27 Millimeter
• Stent Length: 8 Millimeter
• Maximum Stent Diameter: 27 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M927500110 [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: 5
• Public Version Date: 2022-03-17
• Device Publish Date: 2017-02-27

Devices Manufactured by Intersect Ent, Inc.

• M927700110 - Propel: 2022-03-17
• M927500110 - Propel Contour: 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