FDA.reportPublic FDA data

RELIEVA LUMA SENTRY

Primary DI
10705031135635
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
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KAMCANNULA, SINUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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

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
10705031462649RELIEVA TRACTRT1640ART1640A2019-05-31
20705031462592RELIEVA TRACTRT1040AZRT1040AZ2019-05-31
20705031462615RELIEVA TRACTRT1240AZRT1240AZ2019-05-31
20705031462639RELIEVA TRACTRT1440AZRT1440AZ2019-05-31
20705031462653RELIEVA TRACTRT1640AZRT1640AZ2019-05-31
20705031245911TruDi NAVWIRETDNW001ZTDNW001Z2019-10-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09348811099112INKAThe Trustee for KAISER FAMILY TRUSTKAM2025-11-28
09348811099129INKAThe Trustee for KAISER FAMILY TRUSTKAM2025-11-28
04250381847145Cannula for Krause ear polyps snareSpiggle & Theis Medizintechnik GmbHKAM2025-10-10
04250676721075Eicken antrum cannulaSpiggle & Theis Medizintechnik GmbHKAM2025-10-05
04250676745132Cannula RegensburgSpiggle & Theis Medizintechnik GmbHKAM2025-10-05
04250676740618Laryngeal cannulaSpiggle & Theis Medizintechnik GmbHKAM2025-09-12
00757770420797Bausch + LombBausch & Lomb IncorporatedKAM2025-08-15
00757770683505Bausch + LombBausch & Lomb IncorporatedKAM2025-08-05
00194613023133MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
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B3901912038T1Reprocessed 4mm EndoScrub 2 Sheath, 0 deg, w/TubingSURETEK MEDICALKAM2025-05-01
B390197230CVA1Reprocessed 4mm EndoScrub Sheath, 70 deg, K StorzSURETEK MEDICALKAM2025-04-25
00194613065379MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-03-21
00194613102371MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-03-21
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00194613108502MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-03-21
10080196392278MEDLINEMEDLINE INDUSTRIES, INC.KAM2025-02-14
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