FDA.reportPublic FDA data

RELIEVA LUMA

Primary DI
10705031135680
Brand
RELIEVA LUMA
Company
ACCLARENT, INC.
Model
SISLGCAOLYMP
Catalog number
SISLGCAOLYMP
Device description
RELIEVA LUMA LIGHT GUIDE CABLE ADAPTER - OLYMPUS
Published
2017-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EQHSOURCE, CARRIER, FIBEROPTIC LIGHT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EQHSource, Carrier, Fiberoptic LightEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705031135680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503113568010705031135680

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 dry, clean and safe place at room temperature

Sterilization Methods#

Method table
Method
"[""Hydrogen Peroxide"", ""High-level Disinfectant"", ""Moist Heat or Steam Sterilization""]"
Hydrogen Peroxide;High-level Disinfectant;Moist Heat or Steam Sterilization

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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
00190776417680MillenniumAvalign Technologies, Inc.EQH2026-03-04
00198506088841ELMED INCORPORATEDELMED INCORPORATEDEQH2026-02-23
00190776415716MillenniumAvalign Technologies, Inc.EQH2026-02-04
00198506088056ELMED INCORPORATEDELMED INCORPORATEDEQH2026-01-22
00198506087059ELMED INCORPORATEDELMED INCORPORATEDEQH2025-12-03
00198506086786ELMED INCORPORATEDELMED INCORPORATEDEQH2025-11-25
00198506086854ELMED INCORPORATEDELMED INCORPORATEDEQH2025-11-25
00198506086908ELMED INCORPORATEDELMED INCORPORATEDEQH2025-11-25
00198506086250ELMED INCORPORATEDELMED INCORPORATEDEQH2025-10-20
00190776413347MillenniumAvalign Technologies, Inc.EQH2025-10-09
04250676736000Fiberglass light carrierSpiggle & Theis Medizintechnik GmbHEQH2025-09-15
04250676736024Fiberglass light carrierSpiggle & Theis Medizintechnik GmbHEQH2025-09-15
04250676736031Fiberglass light carrierSpiggle & Theis Medizintechnik GmbHEQH2025-09-15
04250676736055Fiberglass light carrierSpiggle & Theis Medizintechnik GmbHEQH2025-09-15
00198506085079ELMED INCORPORATEDELMED INCORPORATEDEQH2025-09-05
00840183530679BR Surgical, LLCBR Surgical, LLCEQH2025-09-05
00190776408534MillenniumAvalign Technologies, Inc.EQH2025-08-19
00194613020132MSI Precision Specialty InstrumentsMed Saver, Inc.EQH2025-08-01
00194613123154MSI Precision Specialty InstrumentsMed Saver, Inc.EQH2025-08-01
00190776406769MillenniumAvalign Technologies, Inc.EQH2025-07-24
00190776406431MillenniumAvalign Technologies, Inc.EQH2025-07-21
00190776377137MillenniumAvalign Technologies, Inc.EQH2025-07-18
00190776406172MillenniumAvalign Technologies, Inc.EQH2025-07-18
00198506084089ELMED INCORPORATEDELMED INCORPORATEDEQH2025-07-17
00190776402815MillenniumAvalign Technologies, Inc.EQH2025-06-30
00198506083716ELMED INCORPORATEDELMED INCORPORATEDEQH2025-06-23
00190776401474MillenniumAvalign Technologies, Inc.EQH2025-06-10
00190776400019MillenniumAvalign Technologies, Inc.EQH2025-06-03
00198506083020ELMED INCORPORATEDELMED INCORPORATEDEQH2025-05-28