Directional Laser Probe with DORC connector.(25 gauge / 0.5 mm)

GUDID 18717872014965

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

Ophthalmic laser system beam guide

• Primary Device ID: 18717872014965
• NIH Device Record Key: 73187aca-e7cd-47e0-b8ab-3dd386d93b46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Directional Laser Probe with DORC connector.(25 gauge / 0.5 mm)
• Version Model Number: 7225.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	08717872014968 [Primary]
GS1	18717872014965 [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

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