FDA.reportPublic FDA data

Vortex Surgical Inc

Primary DI
00810123480876
Brand
Vortex Surgical Inc
Company
Vortex Surgical, Inc.
Model
VS0350.25
Device description
25ga Retractable ILM Membrane Elevator Box of 5
Published
2023-02-02
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
HNQHook, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNQHook, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810123480913PrimaryGS10
00810123480876Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810123480913008101234809138101234809130810123480913
00810123480876008101234808768101234808760810123480876

GMDN Terms#

Term, Definition table
TermDefinition
Epiretinal/inner limiting membrane scraper, single-useA hand-held manual surgical instrument intended to be used during posterior segment surgery to lift the inner limiting membrane (ILM) and/or an epiretinal membrane (ERM), and which may have additional posterior segment membrane manipulation uses. It includes a dedicated textured tip (e.g., diamond-dusted polymer) intended to effectively grip/lift the membrane for further manipulation (e.g., with forceps); it may additionally include non-powered features (e.g., fibreoptics) to allow cold light to be directed to the surgical site. 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
true
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
00190776433185MillenniumAvalign Technologies, Inc.HNQ2026-10-01
00190776432768MillenniumAvalign Technologies, Inc.HNQ2026-09-29
03700483630219MORIAMORIA SAHNQ2026-09-25
00190776423940MillenniumAvalign Technologies, Inc.HNQ2026-08-27
00190776419714MillenniumAvalign Technologies, Inc.HNQ2026-08-25
G22314029320Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2026-08-03
B382S340861340Surgical DirectSurgical Direct, Inc.HNQ2026-07-31
B382S344922000Surgical DirectSurgical Direct, Inc.HNQ2026-07-31
00198506092145ELMED INCORPORATEDELMED INCORPORATEDHNQ2026-07-27
G22312240810Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2026-07-27
G223140340L0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2026-07-27
G223145830T0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2026-07-27
00190776400378MillenniumAvalign Technologies, Inc.HNQ2026-07-17
00190776395728MillenniumAvalign Technologies, Inc.HNQ2026-07-14
13700773729644IRIS RETRACTOR 5 HOOKSFCI S A S FCI 20 22HNQ2026-07-09
00757770451531Bausch + LombBausch & Lomb IncorporatedHNQ2026-06-22
04251047903076Kuglen Iris Hook and Lens ManipulatorA1 Medical GmbHHNQ2026-06-09
04251047903359Sinskey II Lens Manipulating HookA1 Medical GmbHHNQ2026-06-09
04251047904745Sinskey II Lens Manipulating HookA1 Medical GmbHHNQ2026-06-09
04251047905346Kuglen Iris Hook and Lens ManipulatorA1 Medical GmbHHNQ2026-06-09
04251047925849Vera Fixation HookA1 Medical GmbHHNQ2026-05-29
00190776421151MillenniumAvalign Technologies, Inc.HNQ2026-05-04
00190776420833MillenniumAvalign Technologies, Inc.HNQ2026-04-30
00757770522750Bausch + LombBausch & Lomb IncorporatedHNQ2026-04-30
00757770636082Bausch + LombBausch & Lomb IncorporatedHNQ2026-04-30
00190776420086MillenniumAvalign Technologies, Inc.HNQ2026-04-16
00190776420093MillenniumAvalign Technologies, Inc.HNQ2026-04-16
00190776419912MillenniumAvalign Technologies, Inc.HNQ2026-04-15
00190776414214MillenniumAvalign Technologies, Inc.HNQ2025-10-22
00810163790447Diamatrix Ltd.DiamatrixHNQ2025-10-21