Disposable Vitrectomy Lenses, type 1284.DD/ED/GD/ID/FD. 1284.DIS

GUDID 08717872004280

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

Vitrectomy contact lens, single-use

• Primary Device ID: 08717872004280
• NIH Device Record Key: c645e3dd-3def-497f-bea3-f77db9f31e97
• Commercial Distribution Discontinuation: 2024-05-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Disposable Vitrectomy Lenses, type 1284.DD/ED/GD/ID/FD.
• Version Model Number: 1284.DIS
• Catalog Number: 1284.DIS
• Company DUNS: 407522184
• Company Name: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
• Device Count: 5
• 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	08717872004280 [Primary]
GS1	18717872004287 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033950

FDA Product Code

• HJK: Lens, Contact, Polymethylmethacrylate, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2026-01-23
• Device Publish Date: 2016-09-23

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
• 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