FDA.reportPublic FDA data

RELIEVA TRACT

Primary DI
10705031462649
Brand
RELIEVA TRACT
Company
ACCLARENT, INC.
Model
RT1640A
Catalog number
RT1640A
Device description
RELIEVA TRACT BALLOON DILATION SYSTEM, 16X40MM
Published
2019-05-31
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
QGKBalloon, nasal airway

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QGKBalloon, Nasal AirwayEar, Nose, Throat1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183090000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183090000Relieva Tract Balloon Dilation SystemAcclarent, Inc.2019-04-19QGK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705031462646PackageGS15In Commercial Distribution
10705031462649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503146264620705031462646
1070503146264910705031462649

GMDN Terms#

Term, Definition table
TermDefinition
Nasal/paranasal balloon catheter, non-trackingA 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
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
361092450
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031063549RELIEVA SIDEKICK LPSDKKLPSDKKLP2016-10-01
10705031200258RELIEVA ULTIRRABC0516RUBC0516RU2016-10-01
10705031200272RELIEVA ULTIRRABC0616RUBC0616RU2016-10-01
10705031200289RELIEVA ULTIRRABC0716RUBC0716RU2016-10-01
10705031200296RELIEVA ULTIRRABC0724RUBC0724RU2016-10-01
10705031205871RELIEVA VORTEX 2RV02RV022016-10-01
10705031237087ACCLARENT NAVWIREGW35150NZGW35150NZ2017-08-01
10705031238701RELIEVA ULTIRRA NAVBC0516RUNBC0516RUN2017-08-01
10705031241008RELIEVA SPINPLUS NAVRSP0516MFSNRSP0516MFSN2018-02-09
10705031241015RELIEVA SPINPLUS NAVRSP0616MFSNRSP0616MFSN2018-02-18
10705031245907TruDi NAVWIRETDNW001TDNW0012019-10-20
10705031462588RELIEVA TRACTRT1040ART1040A2019-05-31
10705031462601RELIEVA TRACTRT1240ART1240A2019-05-31
10705031462625RELIEVA TRACTRT1440ART1440A2019-05-31
20705031462592RELIEVA TRACTRT1040AZRT1040AZ2019-05-31
20705031462615RELIEVA TRACTRT1240AZRT1240AZ2019-05-31
20705031462639RELIEVA TRACTRT1440AZRT1440AZ2019-05-31
20705031462653RELIEVA TRACTRT1640AZRT1640AZ2019-05-31
20705031245911TruDi NAVWIRETDNW001ZTDNW001Z2019-10-20
20705031131962RELIEVA SIDEKICK LPSDKKLPZSDKKLPZ2016-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705031462588RELIEVA TRACTACCLARENT, INC.QGK2019-05-31
10705031462601RELIEVA TRACTACCLARENT, INC.QGK2019-05-31
10705031462625RELIEVA TRACTACCLARENT, INC.QGK2019-05-31
20705031462585RELIEVA TRACTACCLARENT, INC.QGK2019-05-31
20705031462608RELIEVA TRACTACCLARENT, INC.QGK2019-05-31
20705031462622RELIEVA TRACTACCLARENT, INC.QGK2019-05-31
20705031462646RELIEVA TRACTACCLARENT, INC.QGK2019-05-31
20705031462592RELIEVA TRACTACCLARENT, INC.QGK2019-05-31
20705031462615RELIEVA TRACTACCLARENT, INC.QGK2019-05-31
20705031462639RELIEVA TRACTACCLARENT, INC.QGK2019-05-31
20705031462653RELIEVA TRACTACCLARENT, INC.QGK2019-05-31