25G Two Dimensional Cutter – 16k CPM 8278.VIT25

GUDID 18717872031962

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

Ophthalmic surgical instrument handle, pneumatic Ophthalmic surgical instrument handle, pneumatic Ophthalmic surgical instrument handle, pneumatic Ophthalmic surgical instrument handle, pneumatic Ophthalmic surgical instrument handle, pneumatic Ophthalmic surgical instrument handle, pneumatic Ophthalmic surgical instrument handle, pneumatic Ophthalmic surgical instrument handle, pneumatic Ophthalmic surgical instrument handle, pneumatic Ophthalmic surgical instrument handle, pneumatic Ophthalmic surgical instrument handle, pneumatic Ophthalmic surgical instrument handle, pneumatic Ophthalmic surgical instrument handle, pneumatic Ophthalmic surgical instrument handle, pneumatic Ophthalmic surgical instrument handle, pneumatic Ophthalmic surgical instrument handle, pneumatic

• Primary Device ID: 18717872031962
• NIH Device Record Key: 50d44c0d-4178-4466-9435-e4a0b7ce9c17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 25G Two Dimensional Cutter – 16k CPM
• Version Model Number: 8278.VIT25
• Catalog Number: 8278.VIT25
• 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	08717872031965 [Primary]
GS1	18717872031962 [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.

• 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
• 18717872035311 - EVA NEXUS™ Posterior 25G TDC Pack: 2024-02-29