FDA Registration Active 🇳🇱 Netherlands

Endo-diathermy handle, straight pointed tip.

Reg #: 9611516 · FEI: 3002806863 · Expires 2025
Products
3
Proprietary Names
75
Establishment Types
2
Classifications
3

Registration Details

Registration Name
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Registration Number
9611516
FEI Number
3002806863
Status
Active
Expiry Year
2025
Initial Importer
No
Address
SCHEIJDELVEWEG 2
City
ZUIDLAND Zuid-Holland
Country
NL

Regulatory Submissions

510(k) Number
K190875

Owner / Operator

Firm Name
D.O.R.C. Dutch Ophthalmic Research Center (International) B.
Operator Number
8030460
Address
SCHEIJDELVEWEG 2, --
City
ZUIDLAND
State
Zuid-Holland
Postal Code
3214 VN
Country
NL
Correspondent
Michel - van der Schans

US Agent

Business Name
Dutch Ophthalmic USA
Contact Name
Deborah Thibodeaux
Address
10 Continental Drive, Bldg 1
City
Exeter
State
NH
ZIP
03833
Country
US
Phone
603 7786929 ext. 170

Products

Device Name Product Code
Laser, Ophthalmic HQF
Unit, Phacofragmentation HQC
Instrument, Vitreous Aspiration And Cutting, Ac-Powered HQE

Proprietary Names

Endo-diathermy handle, straight pointed tip. Disposable phaco set with 45 angled flared needle Shielded TotalView Endoillumination Probe, including illuminated scleral depressor 27G Ultra Short Disposable 8000 CPM TDC cutter Diathermy cable Disposable phaco set with 45 straight flared needle Curved tip for universal I/A handpiece TotalView Endoillumination Probe, including illuminated scleral depressor Disposable EVA VGPC Input Set Straight phaco needle EVA Cartridge with 0.5 L Collection Bag Universal PVC infusion line for 23G cannula system for VFI/VFE Reusable phaco sleeve Disposable EVA Irrigation and Aspiration Tubing Triple step flared phaco needle Safety filter for Leica Microscopes, Passive EVA Flight Case Disposable phaco fragmentation needle, incl. wrench Exo diathermy handle with 45 curved tip, diameter 1.3 mm. Phaco Sure Touch Handpiece Safety filter for Leica Microscopes, Manual EVA Mayo Arm Disposable phaco set with 30 angled flared needle Disposable tubings complete with filter for air-fluid exchange Straight tip for universal I/A handpiece Cleaning adaptor for phaco sleeve Universal I/A handpiece, excl. tips Cleaning adapter for phaco needle Irrigation sleeve for phaco needle. Reusable phaco set with 45 straight flared needle Disposable EVA Air Fluid Dual Tubing EVA, combined machine including Laser (DORC connector) Disposable EVA Double Irrigation Line with Air Exchange Triple step angled flared phaco needle. (disposable) Endoillumination Probe, including illuminated scleral depressor Disposable High Speed Cutter VFI Pack for Silicone Oil syringes Disposable infusion sleeve Disposable EVA Gravity Input Set Reusable phaco set with 30 angled flared needle Two Dimensional Cutter – 16k CPM EVA Custom TDC Vitrectomy Pack VGPC Input Disposable test chamber for phaco handpiece Reusable phaco set with 45 angled flared needle Disposable EVA Accessory Set Bimanual irrigation/aspiration set Endo-diathermy handle, straight pointed tip.(20 gauge / 0.9 mm) Featherlight micro Phaco emulsification/fragmentation handpiece. Reusable phaco set with 30 straight flared needle EVA Vitrectomy Pack Gravity Input 27G Ultra Short Shielded TotalView Endoillumination Probe, Including scleral depressor Disposable High Speed TDC Cutter DORC Continuum range EVA Vitrectomy Pack VGPC Input EVA Dust Cover Straight phaco needle. (disposable) EVA TDC Vitrectomy Pack Gravity Input Disposable infusion sleeve phaco needle including test chamber EVA, anterior machine Disposable EVA Collection Bag 0.5 L EVA TDC Vitrectomy Pack VGPC Input Bipolar Coagulation Forceps, 12 cm, angled, excl. cable Disposable frosted scleral depressor Test chamber for phaco handpiece Safety filter for Zeis/Moeller-Wedel Microscopes, Manual Disposable phaco set with 30 straight flared needle Phaco emulsification handpiece. Triple step angled flared phaco needle Safety filter for Zeiss/Moeller-Wedel Microscopes, Passive Universal metal wrench for star phaco needles EVA, combined machine Disposable EVA Closure Plug Aspiration EVA TDC Vitrectomy Pack VGPC Input 27G, Ultra short EVA, combined machine including Laser (SMA connector) Disposable EVA Drapes Triple step flared phaco needle. (disposable)

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device