Home GUDID 00817470009729 ENT Sinus
Primary DI 00817470009729
Brand ENT Sinus
Company Smith & Nephew, Inc.
Model 650-60100S
Catalog number 650-60100S
Device description VENTERA SINUS DILATION BALLOON 1-PACK
Published 2015-08-30
Public version status Update
Distribution status Not 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 LRC INSTRUMENT, ENT MANUAL SURGICAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LRC Instrument, Ent Manual Surgical Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00817470009729 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 00817470009729 00817470009729 817470009729 0817470009729
GMDN Terms# Term, Definition table Term Definition Nasal/paranasal balloon catheter A sterile flexible tube with an inflatable balloon at its distal tip designed to gently restructure nasal passages and dilate obstructed sinus ostia during a surgical procedure (sinuplasty), typically to treat sinusitis, and/or to gently restructure nasal passages to temporarily relieve nasal obstruction/congestion. The device typically consists of a single-lumen tube with a connector at the proximal end for attachment to an inflation device. This is a single-use device.
Regulatory Flags# DUNS number 045483575 Device count 1 Lot or batch true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00885556833933 Salto Talaris Total Ankle Prosthesis MJU952T MJU952T 2022-12-22 00885556833940 Salto Talaris Total Ankle Prosthesis MJU953T MJU953T 2022-12-22 00885556833957 Salto Talaris Total Ankle Prosthesis MJV219T MJV219T 2022-12-22 00885556833964 Salto Talaris Total Ankle Prosthesis MJV220T MJV220T 2022-12-22 00885556833971 Salto Talaris Total Ankle Prosthesis MJV221T MJV221T 2022-12-22 00885556833988 Salto Talaris Total Ankle Prosthesis MJV229T MJV229T 2022-12-22 00885556834237 Silicone Toe System CGT-205T CGT-205T 2022-12-22 00885556834251 Silicone Toe System CGT-305T CGT-305T 2022-12-22 00885556834299 Silicone Toe System CGT-505T CGT-505T 2022-12-22 00885556835029 Ti6 Internal Fixation System DS1007 DS1007 2022-12-22 00885556835203 Surgical Instruments FS-1006 FS-1006 2022-12-22 00885556836187 Ti6 Internal Fixation System TH3018 TH3018 2022-12-22 00885556837856 Total Foot System 2 2204250 2204250 2022-12-22 00885556838785 Total Foot System 2 2823027 2823027 2022-12-21 00885556841631 XT Revision Ankle Replacement System MJU984T MJU984T 2022-12-21 00885556841778 XT Revision Ankle Replacement System MJV222T MJV222T 2022-12-21 00885556841785 XT Revision Ankle Replacement System MJV223T MJV223T 2022-12-21 00885556854921 Freedom Wrist Arthroplasty System 348047 348047 2022-12-22 00885556856680 Surgical Instruments EXT-200-00 EXT-200-00 2022-12-22 00885556860168 Titan Modular Shoulder System 2.5 DRL-0923-047-001 DRL-0923-047-001 2022-12-22
Other Devices Sharing Product Codes#