FDA.reportPublic FDA data

Vortex Surgical Inc.

Primary DI
00810123483662
Brand
Vortex Surgical Inc.
Company
Vortex Surgical, Inc.
Model
VS0390
Device description
Lindsell Sutured IOL Marker
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
HMQMarker, Sclera

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMQMarker, ScleraOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810123483662PrimaryGS10
00810123483655Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810123483662008101234836628101234836620810123483662
00810123483655008101234836558101234836550810123483655

GMDN Terms#

Term, Definition table
TermDefinition
Scleral marker, single-useA manual instrument intended to be used to indent or imprint the surface of the sclera during an ophthalmic surgical or perioperative procedure. It is typically a hand-held instrument or a thimble-like device (placed on the end of a finger) and is made of metal (e.g., high-grade stainless steel) or synthetic polymer materials. Various types are available, including the Gass scleral marker that creates a minuscule indentation, the Awh scleral marker that creates parallel scored lines, and the Awh horseshoe design. The device is typically used for retinal detachment surgery. 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
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
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
00757770498758Bausch + LombBausch & Lomb IncorporatedHMQ2025-08-04
00194613022297MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613084059MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613086541MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613086558MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613086565MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613086572MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613087197MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613087487MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613087524MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613099817MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613101473MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613110345MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613110659MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613111151MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613111304MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613111526MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613121372MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613121426MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613123697MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00810123483655Vortex Surgical Inc.Vortex Surgical, Inc.HMQ2025-04-18
00194613086534MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-03-21
00194613087265MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-03-21
00194613109660MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-03-21
00194613111168MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-03-21
00194613111892MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-03-21
00194613040918MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2024-08-15
00194613040925MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2024-08-15
00194613040932MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2024-08-15
00194613040949MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2024-08-15