Home GUDID M927700110
Propel
Primary DI M927700110
Brand Propel
Company Intersect Ent, Inc.
Model 70011
Device description Propel sinus implant
Published 2014-07-29
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name OWO Drug-Eluting Sinus Stent
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OWO Drug-Eluting Sinus Stent Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M927700110 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Paranasal sinus spacer A sterile device temporarily implanted into the sinus to maintain an opening and prevent obstruction. It is used for the local moistening of the sinuses through delivery of a selected fluid (e.g., saline or a drug) to treat sinusitis. It is typically designed as a microflow catheter with a micropore reservoir at the distal end which gradually releases the fluid. The implantation procedure is assisted through fluoroscopy or endoscopy. A disposable sinus spacer deployment device will typically be included.
Device Sizes# Type, Value, Unit table Type Value Unit Maximum Stent Diameter 50 Millimeter Stent Length 25 Millimeter
Regulatory Flags# DUNS number 876715355 Device count 1 Combination product true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M927500110 Propel Contour 50011 2017-02-27 M927600110 Propel Mini 60011 2014-07-29 M927600440 PROPEL Mini Sinus Implant with Straight Delivery System 60044 2020-10-26 M92710061 Propel Mini Straight Delivery System (SDS) Single Unit 10061 2019-07-30
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00763000710279 PROPEL MEDTRONIC XOMED, INC. OWO 2023-07-08 00763000710330 PROPEL MEDTRONIC XOMED, INC. OWO 2023-07-08 00763000710392 PROPEL MEDTRONIC XOMED, INC. OWO 2023-07-08 00763000710453 PROPEL MEDTRONIC XOMED, INC. OWO 2023-07-08 20763000710303 PROPEL MEDTRONIC XOMED, INC. OWO 2023-07-08 20763000710365 PROPEL MEDTRONIC XOMED, INC. OWO 2023-07-08 20763000710426 PROPEL MEDTRONIC XOMED, INC. OWO 2023-07-08 20763000710464 PROPEL MEDTRONIC XOMED, INC. OWO 2023-07-08 M927600440 PROPEL Mini Sinus Implant with Straight Delivery System Intersect Ent, Inc. OWO 2020-10-26 M92710061 Propel Mini Straight Delivery System (SDS) Single Unit Intersect Ent, Inc. OWO 2019-07-30 M927500110 Propel Contour Intersect Ent, Inc. OWO 2017-02-27 M927600110 Propel Mini Intersect Ent, Inc. OWO 2014-07-29