27G Two Dimensional Cutter – 20k CPM

GUDID 18717872036547

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

Ophthalmic surgical instrument handle, pneumatic

• Primary Device ID: 18717872036547
• NIH Device Record Key: 53275b2c-f140-4fae-8577-872f4379858e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 27G Two Dimensional Cutter – 20k CPM
• Version Model Number: 9268.VIT27-00
• 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	08717872036540 [Primary]
GS1	18717872036547 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213467

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: 2025-04-09
• Device Publish Date: 2025-04-01

On-Brand Devices [27G Two Dimensional Cutter – 20k CPM]

• 18717872031887: 9268.VIT27
• 18717872036547: 9268.VIT27-00