FDA.reportPublic FDA data

Vortex Surgical Inc.

Primary DI
00810123483167
Brand
Vortex Surgical Inc.
Company
Vortex Surgical, Inc.
Model
VS0803
Device description
Pupillary Transilluminator
Published
2025-04-18
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

Product Codes#

Code, Name table
CodeName
HJMTransilluminator, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJMTransilluminator, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810123483167PrimaryGS10
00810123483150Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810123483167008101234831678101234831670810123483167
00810123483150008101234831508101234831500810123483150

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic fibreoptic light instrument, single-useA sterile, hand-held, ophthalmic surgical instrument with a thin, rigid, insertion portion, that is inserted into the eye during a surgical intervention for the purpose of conducting a field of cold light to the posterior segment of the eye. It is connected through a permanently attached light cable to a light source. It has a fibreoptic bundle core that conducts the light, and may be provided with an atraumatic tip to allow for extraocular manipulation (orbital depression) with transscleral illumination. This is a single-use device.

Regulatory Flags#

DUNS number
080375891
Device count
5
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810123481842Vortex Surgical Inc.VS0752.232025-04-18
00810123481859Vortex Surgical Inc.VS0752.252025-04-18
00810123482320Vortex Surgical Inc.VS0753.232025-04-18
00810123482344Vortex Surgical Inc.VS0753.252025-04-18
00810123482399Vortex Surgical Inc.VS0751.232025-04-18
00810123482405Vortex Surgical Inc.VS0751.252025-04-18
00810123482795Vortex Surgical Inc.VS0751.272025-04-18
00810123482818Vortex Surgical Inc.VS0753.272025-04-18
00810123482887Vortex Surgical Inc.VS0752.272025-04-18
00810123483617Vortex Surgical Inc.VS0135.252025-04-18
00810123483624Vortex Surgical Inc.VS0135.232025-04-18
00810123483631Vortex Surgical Inc.VS0125.232025-04-18
00810123483648Vortex Surgical Inc.VS0125.252025-04-19
00810123483662Vortex Surgical Inc.VS03902025-04-18
00810123481828Vortex Surgical Inc.VS0752.232025-04-18
00810123481835Vortex Surgical Inc.VS0752.252025-04-18
00810123482313Vortex Surgical Inc.VS0753.232025-04-18
00810123482337Vortex Surgical Inc.VS0753.252025-04-18
00810123482382Vortex Surgical Inc.VS0751.232025-04-18
00810123482375Vortex Surgical Inc.VS0751.252025-04-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04053755202973FINOFF TRANSILLUMINATORHeine Optotechnik GmbH & Co. KGHJM2025-07-17
00810123483150Vortex Surgical Inc.Vortex Surgical, Inc.HJM2025-04-18
0063230700235925GA Midfield Endoillumination ProbePeregrine Surgical, LlcHJM2024-09-24
0063230700236627GA Midfield Endoillumination ProbePeregrine Surgical, LlcHJM2024-09-24
0063230700237323GA Midfield Endoillumination ProbePeregrine Surgical, LlcHJM2024-09-24
1063230700235625GA Midfield Endoillumination ProbePeregrine Surgical, LlcHJM2024-09-24
1063230700236327GA Midfield Endoillumination ProbePeregrine Surgical, LlcHJM2024-09-24
1063230700237023GA Midfield Endoillumination ProbePeregrine Surgical, LlcHJM2024-09-24
04053755119943OPHTHALMIC EXAMINATION LAMPHeine Optotechnik GmbH & Co. KGHJM2022-12-21
04053755120109OPHTHALMIC EXAMINATION LAMPHeine Optotechnik GmbH & Co. KGHJM2022-12-21
04053755200429FINOFF TRANSILLUMINATORHeine Optotechnik GmbH & Co. KGHJM2022-12-21
04053755199679WALL TRANSFORMER EN 200Heine Optotechnik GmbH & Co. KGHJM2022-12-12
04053755199686WALL TRANSFORMER EN 200-1Heine Optotechnik GmbH & Co. KGHJM2022-12-12
10812594013079NeoGlo® DisposableNeotech Products LLCHJM2021-05-20
10812594013086NeoGlo® DisposableNeotech Products LLCHJM2021-05-20
00812594013072NeoGlo DisposableNEOTECH PRODUCTS, INC.HJM2021-05-20
00812594013089NeoGlo DisposableNEOTECH PRODUCTS, INC.HJM2021-05-20
10841305112138SynergeticsSYNERGETICS USA, INC.HJM2020-05-31
20841305112142SynergeticsSYNERGETICS USA, INC.HJM2020-05-31
07290109140766Acculite™ EndoOcular®LUMENIS INC.HJM2016-09-25
17290109140763Acculite™  EndoOcular®LUMENIS INC.HJM2016-09-25
B396050080VT0ESIFTT MEDICAL, INC.HJM2016-09-16
B396050100VT0ESIFTT MEDICAL, INC.HJM2016-09-16
B3960501020ESIFTT MEDICAL, INC.HJM2016-09-16
B3960501120ESIFTT MEDICAL, INC.HJM2016-09-16
B396MSK1116050ESIFTT MEDICAL, INC.HJM2016-09-16
07290109140759Acculite™ EndoOcular®LUMENIS INC.HJM2016-09-12
17290109140756Acculite™  EndoOcular®LUMENIS INC.HJM2016-09-12
05055272707794Finhoff Transilluminator 2.8vKEELER LIMITEDHJM2016-08-16
05055272715140Transilluminator 3.5v in cartonKEELER LIMITEDHJM2016-08-16