FDA.reportPublic FDA data

VitreQ

Primary DI
08719214222222
Brand
VitreQ
Company
Vitreq B.V.
Model
LF27.D01
Device description
27G Standard Light Fibers
Published
2019-05-12
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MPAEndoilluminator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPAEndoilluminatorGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719214222215PackageGS15In Commercial Distribution
08719214222222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719214222215087192142222158719214222215
08719214222222087192142222228719214222222

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.

Contacts#

Phone, Email table
PhoneEmail
1.866.906.8080customersupport@bvimedical.com

Regulatory Flags#

DUNS number
491393613
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719214220532VitreQFC23.R022022-10-13
08719214220549VitreQFC23.R032022-10-13
08719214220556VitreQFC23.R042022-10-13
08719214220563VitreQFC23.R052022-10-13
08719214220570VitreQFC25.R022022-10-13
08719214220587VitreQFC25.R032022-10-13
08719214220594VitreQFC25.R042022-10-13
08719214220600VitreQFC25.R052022-10-13
08719214220617VitreQFC27.R052022-10-13
08719214220655VitreQSC23.R012022-10-21
08719214220662VitreQSC23.R022022-10-21
08719214220679VitreQSC23.R032022-10-21
08719214220686VitreQSC25.R012022-10-21
08719214220693VitreQSC25.R022022-10-21
08719214220709VitreQSC25.R032022-10-21
08719214220723VitreQSC27.R032022-10-21
08719214221782VitreQFC00.R032022-10-13
08719214221799VitreQFC23.R062022-10-13
08719214221805VitreQFC25.R062022-10-13
08719214221997VitreQFC23.R072022-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00893872001653iTrack 250ENova Eye, Inc.MPA2026-05-05
00817325025010iChopperMEDIMAX TECH INC.MPA2026-04-30
00893872001684iTrack AdvanceNova Eye, Inc.MPA2026-04-15
00893872001660iLuminNova Eye, Inc.MPA2026-01-09
00840096215304XLEND23MULTIFLEXKATALYST SURGICAL LLCMPA2025-06-24
00840096215311XLEND25MULTIFLEXKATALYST SURGICAL LLCMPA2025-06-24
00810123483648Vortex Surgical Inc.Vortex Surgical, Inc.MPA2025-04-19
00810123483617Vortex Surgical Inc.Vortex Surgical, Inc.MPA2025-04-18
00810123483624Vortex Surgical Inc.Vortex Surgical, Inc.MPA2025-04-18
00810123483631Vortex Surgical Inc.Vortex Surgical, Inc.MPA2025-04-18
08717872035499TotalView Endoillumination Probe, with 2 exchangeable tips.(23 gauge / 0.6 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-04-01
08717872035543TotalView Chandelier for cannula system.(25 gauge / 0.5 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-04-01
18717872035496TotalView Endoillumination Probe, with 2 exchangeable tips.(23 gauge / 0.6 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-04-01
18717872035540TotalView Chandelier for cannula system.(25 gauge / 0.5 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-04-01
08717872035406Endoillumination Probe, including illuminated scleral depressor.(20 gauge / 0.9 D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
0871787203542023 GA./0.6mm Shielded TotalView Endo. Probe, including ill. scleral depressorD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
08717872035444Shielded TotalView Endoillumination Probe, including illuminated scleral depressD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
08717872035451TotalView Endoillumination Probe, including illuminated scleral depressor.(23 gaD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
08717872035468TotalView Endoillumination Probe, including illuminated scleral depressor.(25 gaD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
08717872035475Endoillumination Probe, including illuminated scleral depressor.(25 gauge / 0.5 D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
08717872035482Endoillumination Probe, including illuminated scleral depressor.(23 gauge / 0.6 D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
08717872035505TotalView Endoillumination Probe, including illuminated scleral depressor.(20 gaD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
08717872035512Disposable Eckardt Twinlight Chandelier. (27 gauge / 0.4mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
08717872035529Eckardt TwinLight Chandelier with Photon connector and guidance needle.(27 gaugeD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
08717872035550Disposable Chandelier fiber (one fiber) with Photon connector and guidance needlD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
08717872035567Spaide TotalView Endoillumination Probe, including illuminated scleral depressorD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
08717872035581TotalView Chandelier for Eckardt cannula system.(23 gauge / 0.6 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
08717872035598Combined 23G Eckardt Multi-Fiber Endoillumination Probe / Chandelier (23 gauge /D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
18717872035403Endoillumination Probe, including illuminated scleral depressor.(20 gauge / 0.9 D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
1871787203542723 GA./0.6mm Shielded TotalView Endo. Probe, including ill. scleral depressorD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31