Directional Laser Probe with DORC connector.(27 gauge / 0.4 mm)

GUDID 18717872031900

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

Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide

• Primary Device ID: 18717872031900
• NIH Device Record Key: ad395f3c-bc08-4037-8629-2d4228041f6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Directional Laser Probe with DORC connector.(27 gauge / 0.4 mm)
• Version Model Number: 7227.DORC
• 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	08717872031903 [Primary]
GS1	18717872031900 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213467

FDA Product Code

• HQF: Laser, Ophthalmic

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: 2022-07-11
• Device Publish Date: 2022-07-01

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

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• 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