FDA.reportPublic FDA data

RELIEVA LUMA SENTRY

Primary DI
20705031135632
Brand
RELIEVA LUMA SENTRY
Company
ACCLARENT, INC.
Model
SIS100B
Catalog number
SIS100B
Device description
RELIEVA LUMA SENTRY SINUS ILLUMINATION SYSTEM
Published
2016-10-01
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

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
20705031135632PackageGS15In Commercial Distribution
10705031135635PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503113563220705031135632
1070503113563510705031135635

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(877)775-2789xx@xx.xx
+1(800)654-2873custsvcnj@integralife.com

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#

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