Vortex Surgical Inc.

Primary DI
00810123483150
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
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080375891
Device count
5
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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
00810123483167Vortex Surgical Inc.VS08032025-04-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04053755202973FINOFF TRANSILLUMINATORHeine Optotechnik GmbH & Co. KGHJM2025-07-17
00810123483167Vortex 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