Home GUDID 20763000710426 PROPEL
Primary DI 20763000710426
Brand PROPEL
Company MEDTRONIC XOMED, INC.
Model 50011-
Device description IMPLANT 50011- PROPEL CONTOUR
Published 2023-07-08
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
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 20763000710426 Package GS1 5 In Commercial Distribution 00763000710392 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 20763000710426 20763000710426 00763000710392 00763000710392 763000710392 0763000710392
GMDN Terms# Term, Definition table Term Definition Drug-eluting paranasal sinus stent A sterile bioabsorbable device with a drug coating intended to be implanted into a paranasal sinus (e.g., frontal, sphenoidal, ethmoidal, maxillary) to maintain sinus patency in the treatment of chronic sinusitis. The drug coating is intended to reduce inflammation and polyps to facilitate the separation of sinus mucosal tissues. The device is made of synthetic polymer(s) capable of being degraded and absorbed by body tissues, and is designed to allow for the slow release of the drug coating. It is endoscopically implanted via the nasal passageway; disposable devices associated with implantation may be included.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 835465063 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product true Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# 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 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 M927700110 Propel Intersect Ent, Inc. OWO 2014-07-29 M927600110 Propel Mini Intersect Ent, Inc. OWO 2014-07-29
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