Disposable EVA Air Fluid Dual Tubing

GUDID 18717872036585

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

Surgical irrigation/aspiration tubing set

• Primary Device ID: 18717872036585
• NIH Device Record Key: 243dbf1e-46ab-4849-874c-097a097325fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable EVA Air Fluid Dual Tubing
• Version Model Number: 8110.AFD01-00
• 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	08717872036588 [Primary]
GS1	18717872036585 [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: 2025-04-08
• Device Publish Date: 2025-03-31

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

• 08717872001401 - Disposable Pneumatic Vitrectome.(25 gauge / 0.5 mm)(working with 30 P.S.I., max.: 2026-01-23
• 08717872001425 - Disposable Pneumatic Vitrectome.(20 gauge / 0.9 mm)(working with 37 P.S.I., max.: 2026-01-23
• 08717872003085 - Infusion cannula forceps: 2026-01-23
• 08717872003115 - Scleral plug forceps: 2026-01-23
• 08717872003375 - Charles Flute instrument.: 2026-01-23
• 08717872004280 - Disposable Vitrectomy Lenses, type 1284.DD/ED/GD/ID/FD.: 2026-01-23
• 08717872008578 - Disposable Pneumatic Vitrectome.(23 gauge / 0.6 mm)(working with 37 P.S.I., max.: 2026-01-23
• 08717872016771 - Disposable High-Speed Vitrectome.(27 gauge / 0.4 mm)(working with 37 P.S.I., max: 2026-01-23