23G Two Dimensional Cutter – 16k CPM 8278.VIT23

GUDID 18717872031948

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

Ophthalmic surgical instrument handle, pneumatic

• Primary Device ID: 18717872031948
• NIH Device Record Key: 6bf32499-7a6b-4d58-8ac9-5d62ee8a6e1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 23G Two Dimensional Cutter – 16k CPM
• Version Model Number: 8278.VIT23
• Catalog Number: 8278.VIT23
• Company DUNS: 407522184
• Company Name: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
• Device Count: 6
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	08717872031941 [Primary]
GS1	18717872031948 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190875

FDA Product Code

• HQE: Instrument, Vitreous Aspiration And Cutting, Ac-Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-04
• Device Publish Date: 2021-05-27

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