Home GUDID 20705031462585 RELIEVA TRACT
Primary DI 20705031462585
Brand RELIEVA TRACT
Company ACCLARENT, INC.
Model RT1040A
Catalog number RT1040A
Device description RELIEVA TRACT BALLOON DILATION SYSTEM, 10X40MM
Published 2019-05-31
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name QGK Balloon, nasal airway
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QGK Balloon, Nasal Airway Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20705031462585 Package GS1 5 In Commercial Distribution 10705031462588 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20705031462585 20705031462585 10705031462588 10705031462588
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.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in a cool, dry place
Regulatory Flags# DUNS number 361092450 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true 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 10705031462588 RELIEVA TRACT ACCLARENT, INC. QGK 2019-05-31 10705031462601 RELIEVA TRACT ACCLARENT, INC. QGK 2019-05-31 10705031462625 RELIEVA TRACT ACCLARENT, INC. QGK 2019-05-31 10705031462649 RELIEVA TRACT ACCLARENT, INC. QGK 2019-05-31 20705031462608 RELIEVA TRACT ACCLARENT, INC. QGK 2019-05-31 20705031462622 RELIEVA TRACT ACCLARENT, INC. QGK 2019-05-31 20705031462646 RELIEVA TRACT ACCLARENT, INC. QGK 2019-05-31 20705031462592 RELIEVA TRACT ACCLARENT, INC. QGK 2019-05-31 20705031462615 RELIEVA TRACT ACCLARENT, INC. QGK 2019-05-31 20705031462639 RELIEVA TRACT ACCLARENT, INC. QGK 2019-05-31 20705031462653 RELIEVA TRACT ACCLARENT, INC. QGK 2019-05-31
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