D.A.L.K. Spatula Dissection Set 2110

GUDID 08717872008189

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Ophthalmic surgical probe, reusable
Primary Device ID08717872008189
NIH Device Record Key31e8c7c9-efbc-450c-82f9-14b7e278f13d
Commercial Distribution StatusIn Commercial Distribution
Brand NameD.A.L.K. Spatula Dissection Set
Version Model Number2110
Catalog Number2110
Company DUNS407522184
Company NameD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108717872008189 [Primary]

FDA Product Code

HNDSpatula, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08717872008189]

Moist Heat or Steam Sterilization


[08717872008189]

Moist Heat or Steam Sterilization


[08717872008189]

Moist Heat or Steam Sterilization


[08717872008189]

Moist Heat or Steam Sterilization


[08717872008189]

Moist Heat or Steam Sterilization


[08717872008189]

Moist Heat or Steam Sterilization


[08717872008189]

Moist Heat or Steam Sterilization


[08717872008189]

Moist Heat or Steam Sterilization


[08717872008189]

Moist Heat or Steam Sterilization


[08717872008189]

Moist Heat or Steam Sterilization


[08717872008189]

Moist Heat or Steam Sterilization


[08717872008189]

Moist Heat or Steam Sterilization


[08717872008189]

Moist Heat or Steam Sterilization


[08717872008189]

Moist Heat or Steam Sterilization


[08717872008189]

Moist Heat or Steam Sterilization


[08717872008189]

Moist Heat or Steam Sterilization


[08717872008189]

Moist Heat or Steam Sterilization


[08717872008189]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-14
Device Publish Date2023-07-06

Devices Manufactured by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

18717872035496 - TotalView Endoillumination Probe, with 2 exchangeable tips.(23 gauge / 0.6 mm)2025-04-09
18717872035540 - TotalView Chandelier for cannula system.(25 gauge / 0.5 mm)2025-04-09
18717872036547 - 27G Two Dimensional Cutter – 20k CPM2025-04-09
08717872034720 - EVA Custom TDC Vitrectomy Pack VGPC Input 27G2025-04-08
18717872035397 - Endoillumination Probe, including illuminated scleral depressor. (27 gauge / 0.42025-04-08
18717872035403 - Endoillumination Probe, including illuminated scleral depressor.(20 gauge / 0.9 2025-04-08
18717872035410 - TotalView Endoillumination Probe, including illuminated scleral depressor.(27 ga2025-04-08
18717872035427 - 23 GA./0.6mm Shielded TotalView Endo. Probe, including ill. scleral depressor2025-04-08

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.