FDA.reportPublic FDA data

Lightbox Umbilical

Primary DI
00851354004301
Brand
Lightbox Umbilical
Company
AVINGER, INC.
Model
U250
Catalog number
U250
Device description
Lightbox Umbilical is intended for use in peripheral vascular procedures in conjunction with a compatible Avinger product.
Published
2019-03-21
Public version status
New
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
NQQSystem, Imaging, Optical Coherence Tomography (Oct)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQQSystem, Imaging, Optical Coherence Tomography (Oct)Radiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851354004301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851354004301008513540043018513540043010851354004301

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical atherectomy system generator, mechanical outputA mains electricity (AC-powered) component of a mechanical atherectomy system designed to generate mechanical energy that is typically transmitted through a separate catheter/handpiece for the fragmentation of a chronic partial occlusion (CPO) or chronic total occlusion (CTO) of both coronary and peripheral arteries during an atherectomy procedure. The device may be operated via a remote control or foot-switch and may include an integrated suction/aspiration system.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
650-241-7030tlawson@avinger.com

Regulatory Flags#

DUNS number
003152968
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851354004417Pantheris SVA140-SVA140-SV2019-08-02
00851354004189Ocelot IIIO200O2002019-03-21
00851354004233Ocelot IVO250O2502019-03-21
00851354004271CO2C100C1002019-03-21
00851354004370PantherisA400A4002019-03-21
00851354004387Pantheris A400XA400X2019-03-21
00851354004554Tigereye STO350O3502023-07-24
00851354004493TigereyeO300O3002023-03-14
00851354004509Lightbox L3L300L3002024-01-29
00851354004578Pantheris LVLVA110-LV2024-01-29
00851354004264Sterile DrapeSD100SD1002019-03-21
00851354004004WildcatW400W4002019-03-21
00851354004028WildcatE400E4002019-03-21
00851354004042Kittykat IIW550`W5502019-03-21
00851354004059Kittykat IIE550E5502019-03-21
00851354004073JuiceboxJ100J1002019-03-21
00851354004127Lightbox Umbilical U100U1002019-03-21
00851354004141Ocelot PIXLP135P1352019-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199874783659LIA ConsoleLEADOPTIK INC.NQQ2026-06-01
05415067054920Ultreon™LIGHTLAB IMAGING, INC.NQQ2026-05-19
00812763011007OPUSWAVETerumo Cardiovascular Systems CorporationNQQ2026-05-13
06975417183858PantherisZylox-Tonbridge Medical Technology Co., Ltd.NQQ2026-03-21
06975417183865PantherisZylox-Tonbridge Medical Technology Co., Ltd.NQQ2026-03-21
06975417183872PantherisZylox-Tonbridge Medical Technology Co., Ltd.NQQ2026-03-21
06975417183889PantherisZylox-Tonbridge Medical Technology Co., Ltd.NQQ2026-03-21
06971141530494Cornaris Intravascular Imaging SystemShenzhen Vivolight Medical Device & Technology Co., Ltd.NQQ2025-09-28
06971141530500Cornaris Intravascular Imaging SystemShenzhen Vivolight Medical Device & Technology Co., Ltd.NQQ2025-09-28
03775000102715deepLiveDAMAE MEDICALNQQ2025-09-24
05415067053879ILUMIEN™ OPTIS™ to OPTIS™LIGHTLAB IMAGING, INC.NQQ2025-07-31
05415067047694Ultreon™LIGHTLAB IMAGING, INC.NQQ2024-03-29
00860008045508Starlight Imaging CatheterSpectrawave, Inc.NQQ2024-02-23
00860008045515HyperVue Imaging SystemSpectrawave, Inc.NQQ2024-02-23
00851354004509Lightbox L3AVINGER, INC.NQQ2024-01-29
05415067048882AptiVue™LIGHTLAB IMAGING, INC.NQQ2023-09-29
06932503570022Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
06932503570039Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
06932503570046Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
06932503570053Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
06932503570060Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
06932503570077Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
06932503570084Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
06932503570091Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
06932503570107Luminscan(TM) Disposable Imaging KitMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
16932503570029MTMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
16932503570036MTMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
16932503570043MTMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
16932503570050MTMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11
16932503570067MTMicro-Tech (Nanjing) Co., Ltd.NQQ2023-08-11