FDA.reportPublic FDA data

RELIEVA SPINPLUS NAV

Primary DI
10705031241015
Brand
RELIEVA SPINPLUS NAV
Company
ACCLARENT, INC.
Model
RSP0616MFSN
Catalog number
RSP0616MFSN
Device description
RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT
Published
2018-02-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRCINSTRUMENT, ENT MANUAL SURGICAL
PGWEar, Nose, and Throat Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1
PGWEar, Nose, And Throat Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171687000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171687000Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.2017-09-05LRC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705031241012PackageGS15In Commercial Distribution
10705031241015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503124101220705031241012
1070503124101510705031241015

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
10705031063297INSPIRA AIRBC1040ABC1040A2016-09-01
10705031063310INSPIRA AIRBC1440ABC1440A2016-09-01
10705031131996INSPIRA AIRBC0524ABC0524A2016-09-01
10705031132061INSPIRA AIRBC0724ABC0724A2016-09-01
10705031147737INSPIRA AIRBC1240ABC1240A2016-09-01
10705031147744INSPIRA AIRBC1640ABC1640A2016-09-01
10705031206052INSPIRA AIRBC8524ABC8524A2016-09-01
20705031063089INSPIRA AIRBC0524AZBC0524AZ2016-09-01
20705031063126INSPIRA AIRBC0724AZBC0724AZ2016-09-01
20705031063157INSPIRA AIRBC1040AZBC1040AZ2016-09-01
20705031063171INSPIRA AIRBC1440AZBC1440AZ2016-09-01
20705031147703INSPIRA AIRBC1240AZBC1240AZ2018-03-31
20705031242682INSPIRA AIRBC8524AZBC8524AZ2018-03-31
10705031245853TruDi NAV CableTDNC001TDNC0012018-10-31
10705031245877TruDi NAV SuctionTDNS000ZTDNS000Z2019-01-20
10705031245884TruDi NAV SuctionTDNS070ZTDNS070Z2019-01-20
10705031245891TruDi NAV SuctionTDNS090ZTDNS090Z2019-01-20
20705031245867TruDi NAV CableTDNC001ZTDNC001Z2018-10-31
10705031200258RELIEVA ULTIRRABC0516RUBC0516RU2016-10-01
10705031200272RELIEVA ULTIRRABC0616RUBC0616RU2016-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776432263MillenniumAvalign Technologies, Inc.LRC2026-09-24
00190776432270MillenniumAvalign Technologies, Inc.LRC2026-09-24
00190776431440MillenniumAvalign Technologies, Inc.LRC2026-09-22
00190776432140MillenniumAvalign Technologies, Inc.LRC2026-09-22
04260759931314Flexarm UniversalFiagon GmbHPGW2026-09-20
00190776428020MillenniumAvalign Technologies, Inc.LRC2026-08-27
00190776428174MillenniumAvalign Technologies, Inc.LRC2026-08-27
00844505014762BONE WAX APPLICATORGrace Medical, Inc.LRC2026-08-27
00190776427566MillenniumAvalign Technologies, Inc.LRC2026-08-26
04054462913633evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913732evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913763evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913794evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913824evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913831evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913855evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913893evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914005evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914012evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914036evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914067evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914074evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914081evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914098evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914104evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914111evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914142evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914203evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914234evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914241evonosevonos GmbH & Co. KGLRC2026-08-25