Collection bag for Associate REF: 6279.ASD1 Cartridge. 6279.ASD4

GUDID 18717872013456

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

Ophthalmic surgery fluid collection bag
Primary Device ID18717872013456
NIH Device Record Key20b6f712-ea32-47d1-b501-79b1c221b257
Commercial Distribution StatusIn Commercial Distribution
Brand NameCollection bag for Associate REF: 6279.ASD1 Cartridge.
Version Model Number6279.ASD4
Catalog Number6279.ASD4
Company DUNS407522184
Company NameD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Device Count6
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
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
GS108717872013459 [Primary]
GS118717872013456 [Unit of Use]

FDA Product Code

KYGDevice, Irrigation, Ocular Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-22
Device Publish Date2023-09-14

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

08717872037103 - 25G Extendible subretinal injection cannula (41G)2025-10-06
08717872037110 - 27G Extendible subretinal injection cannula (41G)2025-10-06
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

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