Illuminated infusion cannula, 1.2 mm. 3269.D1D

GUDID 08717872009421

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

Ophthalmic infusion/aspiration cannula, illuminating, single-use

• Primary Device ID: 08717872009421
• NIH Device Record Key: e17f5945-cc29-483d-accb-1098b1e28ce8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Illuminated infusion cannula, 1.2 mm.
• Version Model Number: 3269.D1D
• Catalog Number: 3269.D1D
• 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	08717872009421 [Primary]
GS1	18717872009428 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062895

FDA Product Code

• MPA: Endoilluminator

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: 2019-04-23
• Device Publish Date: 2016-09-23

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

• 18717872034710 - CUSTOM TDC VITREC.PACK VGP 25G: 2024-10-07
• 18717872034932 - 23G High Flow infusion line: 2024-02-29
• 18717872034949 - 25G High Flow infusion line: 2024-02-29
• 18717872034956 - 27G High Flow infusion line: 2024-02-29
• 18717872035106 - EVA NEXUS™ Posterior 23G TDC Pack: 2024-02-29
• 18717872035113 - EVA NEXUS™ Posterior 25G TDC Pack: 2024-02-29
• 18717872035120 - EVA NEXUS™ Posterior 27G TDC Pack: 2024-02-29
• 18717872035304 - EVA NEXUS™ Posterior 23G TDC Pack: 2024-02-29