FDA.reportPublic FDA data

VersaVit

Primary DI
10841305106045
Brand
VersaVit
Company
SYNERGETICS USA, INC.
Model
VERSAVIT
Catalog number
VERSAVIT
Device description
VersaVIT™ Vitrectomy System
Published
2016-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HQEINSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQEInstrument, Vitreous Aspiration And Cutting, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841305106045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084130510604510841305106045

GMDN Terms#

Term, Definition table
TermDefinition
Vitrectomy systemAn assembly of ophthalmic devices intended to deliver energy (e.g., ultrasonic, piezoelectric, pneumatic) through a dedicated hand-held instrument, which converts the energy into an oscillating-cutting action to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. This system will typically consist of a generator to provide the energy, an infusion and suction system to supply replacement fluid and remove debris, a cutting handpiece and cables, and a foot control. This assembly is typically used to treat diabetic vitreous haemorrhage, retinal detachment, epiretinal membrane, and macular hole.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Regulatory Flags#

DUNS number
021056726
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841305101118Synergetics18067180672020-09-18
10841305101064Synergetics18060180602020-05-31
10841305101071Synergetics18061180612020-05-31
10841305101088Synergetics18063180632020-05-31
10841305101095Synergetics18064180642020-05-31
10841305101125Synergetics18069180692020-05-31
10841305101132Synergetics18069W18069W2020-05-31
10841305101156Synergetics31.0231.022020-09-18
10841305101163Synergetics41.0041.002020-09-18
10841305101231Synergetics16579165792020-09-18
10841305101255Synergetics12.06.2512.06.252020-09-18
10841305101309Synergetics17570175702017-12-30
10841305101316Synergetics17580175802020-09-18
10841305101323Synergetics17680176802020-09-18
10841305101330Synergetics19020190202020-09-18
10841305101415Synergetics30.08.2330.08.232020-09-18
10841305101422Synergetics30.08.2530.08.252020-09-18
10841305101439Synergetics30.08.2730.08.272020-09-18
10841305101446Synergetics30.1030.102020-09-18
10841305101453Synergetics30.10.2330.10.232020-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10757770060464Bausch + LombBausch & Lomb IncorporatedHQE2026-04-09
10757770060471Bausch + LombBausch & Lomb IncorporatedHQE2026-04-09
10757770060488Bausch + LombBausch & Lomb IncorporatedHQE2026-04-09
00380650003294UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003300UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003317UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003614UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003621UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003638UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003669UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003676UNITYAlcon Laboratories, Inc.HQE2025-04-08
00380650003683UNITYAlcon Laboratories, Inc.HQE2025-04-08
0871787203654027G Two Dimensional Cutter – 20k CPMD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-04-01
08717872036526EVA Cartridge with 0.5 L Collection BagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036588Disposable EVA Air Fluid Dual Tubing D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036489EVA NEXUS™ Irrigation and Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036496EVA NEXUS™ Infusion Giving SetD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036502EVA Nexus™ Irrigation TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036618EVA Nexus™ Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
08717872036625EVA NEXUS™ cartridge with 0,5 L collection bagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2025-03-31
00380650003324UNITYAlcon Laboratories, Inc.HQE2024-11-19
00380650003348UNITYAlcon Laboratories, Inc.HQE2024-11-19
08717872034713CUSTOM TDC VITREC.PACK VGP 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-09-27
00380650001252UNITYAlcon Laboratories, Inc.HQE2024-07-02
08717872035109EVA NEXUS™ Posterior 23G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035116EVA NEXUS™ Posterior 25G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035123EVA NEXUS™ Posterior 27G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035307EVA NEXUS™ Posterior 23G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035314EVA NEXUS™ Posterior 25G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21
08717872035321EVA NEXUS™ Posterior 27G TDC PackD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQE2024-02-21