FDA.reportPublic FDA data

RELIEVA LUMA SENTRY

Primary DI
20705031135649
Brand
RELIEVA LUMA SENTRY
Company
ACCLARENT, INC.
Model
SIS100BZ
Catalog number
SIS100BZ
Device description
RELIEVA LUMA SENTRY SINUS ILLUMINATION SYSTEM, 1 PK
Published
2016-10-01
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
EQHSOURCE, CARRIER, FIBEROPTIC LIGHT
KAMCANNULA, SINUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EQHSource, Carrier, Fiberoptic LightEar, Nose, Throat1
KAMCannula, SinusGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071845000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071845000RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100AAcclarent, Inc.2007-09-28KAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705031135649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503113564920705031135649

GMDN Terms#

Term, Definition table
TermDefinition
Paranasal sinus-illumination light guide cableA sterile device designed to transmit cold light via a guidewire into the sinus cavities to provide illumination of the operative site during diagnostic and therapeutic procedures in conjunction with other nasal and sinus devices. It is typically a flexible light cable with a fibreoptic core which tapers at the distal end into a long, thin, probe that is capable of being manoeuvred into the various cavities; the proximal end will attach to an appropriate light source. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(650)687-5888xx@xx.xx
+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
10705031462649RELIEVA TRACTRT1640ART1640A2019-05-31
20705031462592RELIEVA TRACTRT1040AZRT1040AZ2019-05-31
20705031462615RELIEVA TRACTRT1240AZRT1240AZ2019-05-31
20705031462639RELIEVA TRACTRT1440AZRT1440AZ2019-05-31
20705031462653RELIEVA TRACTRT1640AZRT1640AZ2019-05-31
20705031245911TruDi NAVWIRETDNW001ZTDNW001Z2019-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506090868ELMED INCORPORATEDELMED INCORPORATEDEQH2026-05-18
B390197230FLA1Reprocessed 4mm EndoScrub Sheath, 45 deg, K StorzSURETEK MEDICALKAM2026-04-30
00198506086250ELMED INCORPORATEDELMED INCORPORATEDEQH2025-10-20
04250381847145Cannula for Krause ear polyps snareSpiggle & Theis Medizintechnik GmbHKAM2025-10-10
00190776413347MillenniumAvalign Technologies, Inc.EQH2025-10-09
14026704933065PILLINGTELEFLEX INCORPORATEDEQH2025-04-28
14026704933041PILLINGTELEFLEX INCORPORATEDEQH2025-03-19
14026704933058PILLINGTELEFLEX INCORPORATEDEQH2025-03-19
10080196392278MEDLINEMEDLINE INDUSTRIES, INC.KAM2025-02-14
10888277371774MEDLINEMEDLINE INDUSTRIES, INC.KAM2025-02-14
04250480112564NASCHÖLLY FIBEROPTIC GmbHEQH2025-01-17
10840199515995Fiberoptic Dual End CableKOROS U.S.A., INC.EQH2024-12-31
10840199516008Fiberoptic Light PortKOROS U.S.A., INC.EQH2024-12-31
10840199516015Fiberoptic Light PortKOROS U.S.A., INC.EQH2024-12-31
00198506061028ELMED INCORPORATEDELMED INCORPORATEDEQH2024-09-05
08904461006835OSSEOUS Suction Tube for Sinus-DisposableEON MEDITECH PRIVATE LIMITEDKAM2024-07-03
08904461006842OSSEOUS Suction Tube for Sinus-DisposableEON MEDITECH PRIVATE LIMITEDKAM2024-07-03
08906039314090OSSEOUS Suction tubes for Nose ReusableEON MEDITECH PRIVATE LIMITEDKAM2024-06-26
08906039315097OSSEOUS Suction tubes for Nose Reusable EON MEDITECH PRIVATE LIMITEDKAM2024-06-26
08904428724062OSSEOUS Suction tubes for SinusEON MEDITECH PRIVATE LIMITEDKAM2024-06-25
08906039313093OSSEOUS Suction Tubes for Nose DisposableEON MEDITECH PRIVATE LIMITEDKAM2024-06-25
08906039313970OSSEOUS Suction tubes for Nose ReusableEON MEDITECH PRIVATE LIMITEDKAM2024-06-25
08906039313994OSSEOUS Suction tubes for Nose ReusableEON MEDITECH PRIVATE LIMITEDKAM2024-06-25
08906039314069OSSEOUS Suction tubes for Nose ReusableEON MEDITECH PRIVATE LIMITEDKAM2024-06-25
08906039314076OSSEOUS Suction tubes for Nose ReusableEON MEDITECH PRIVATE LIMITEDKAM2024-06-25
08906039314977OSSEOUS Suction tubes for Nose ReusableEON MEDITECH PRIVATE LIMITEDKAM2024-06-25
08906039314991OSSEOUS Suction tubes for Nose ReusableEON MEDITECH PRIVATE LIMITEDKAM2024-06-25
08906039315066OSSEOUS Suction tubes for Nose ReusableEON MEDITECH PRIVATE LIMITEDKAM2024-06-25
08906039315073OSSEOUS Suction tubes for Nose ReusableEON MEDITECH PRIVATE LIMITEDKAM2024-06-25
08906039317114OSSEOUS Suction tubes for SinusEON MEDITECH PRIVATE LIMITEDKAM2024-06-25