EVA NEXUS™, Phaco vitrectomy system

GUDID 08717872034423

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

Phacoemulsification/vitrectomy system

• Primary Device ID: 08717872034423
• NIH Device Record Key: 5f30fc2e-2b98-4894-bdde-438eb1e36be5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVA NEXUS™, Phaco vitrectomy system
• Version Model Number: 9000.COMU1
• Company DUNS: 407522184
• Company Name: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717872034423 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213467

FDA Product Code

• HQC: Unit, Phacofragmentation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-09
• Device Publish Date: 2022-08-01

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 CPM: 2025-04-09
• 08717872034720 - EVA Custom TDC Vitrectomy Pack VGPC Input 27G: 2025-04-08
• 18717872035397 - Endoillumination Probe, including illuminated scleral depressor. (27 gauge / 0.4: 2025-04-08
• 18717872035403 - Endoillumination Probe, including illuminated scleral depressor.(20 gauge / 0.9: 2025-04-08
• 18717872035410 - TotalView Endoillumination Probe, including illuminated scleral depressor.(27 ga: 2025-04-08
• 18717872035427 - 23 GA./0.6mm Shielded TotalView Endo. Probe, including ill. scleral depressor: 2025-04-08