FDA.reportPublic FDA data

Shielded TotalView Endoillumination Probe, including illuminated scleral depress

Primary DI
08717872035444
Brand
Shielded TotalView Endoillumination Probe, including illuminated scleral depress
Company
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Model
3269.SBS05-00
Device description
Shielded TotalView Endoillumination Probe, including illuminated scleral depressor.(25 gauge / 0.5 mm)
Published
2025-03-31
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
MPAEndoilluminator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPAEndoilluminatorGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062895000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062895000XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIIIDutch Ophthalmic Research Center International BV2006-10-13MPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717872035444PrimaryGS10
18717872035441Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717872035444087178720354448717872035444
1871787203544118717872035441

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.

Regulatory Flags#

DUNS number
407522184
Device count
6
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717872031804EVA Custom TDC Vitrectomy Pack VGPC Input 23G8523.4222021-06-11
08717872003221Universal silicone infusion line for 20 gauge/0.9 mm cannula system.1279.IA201279.IA202021-02-01
08717872003245Infusion line for 23G / 0.6 mm infusion cannula 1272.ERPP21279.P1279.P2021-02-01
08717872003993Disposable Backflush instrument, with extended silicone tip and active aspiratio1281.TDM1281.TDM2021-02-02
08717872004013Replacement backflush reservoir with active aspiration.1281.XD1281.XD2021-02-02
08717872004075MVR Blade 23-G, angled1282.D061282.D062021-02-09
08717872004099One step stiletto insertor.(23 gauge / 0.6 mm)1282.F061282.F062021-02-09
08717872007403Disposable keratoscope1420.D1420.D2023-09-14
08717872012339Crescent Knife, 2.25, 55°, bevel up51.111851.11182021-01-29
08717872012346Slit Knife, 2.2mm, angled 45°, bibevel51.372251.37222021-01-29
08717872012384MVR Blade 20G, straight51.523051.52302021-01-29
08717872015255Universal silicone infusion line for 20 gauge/0.9 mm cannula system, suitable fo1279.IA20S1279.IA20S2021-02-01
08717872015712MVR Blade 20G, angled52.522052.52202021-01-29
08717872015736Trapezoid Knife 1.2 x 1.4mm, angled53.121453.12142021-01-29
08717872015743Slit Knife, 2.2mm, angled, bevel up53.372253.37222021-01-29
08717872015750Slit Knife, 2.75mm, angled, bevel up53.372753.37272021-01-29
08717872015798Clear Corneal Knife, 2.5mm, angled54.572554.57252021-01-29
08717872015934Stab Knife, 15°51.489151.48912021-01-29
08717872031811EVA Custom TDC Vitrectomy Pack VGPC Input 25G8525.4098525.4012021-06-11
08717872031828EVA Custom TDC Vitrectomy Pack VGPC Input 27G8527.4068525.4012021-06-11

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
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
18717872035441Shielded TotalView Endoillumination Probe, including illuminated scleral depressD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31