Disposable I/A replacement Tubing set for REF: 6279.ASD1 Cartridge, including co 6279.ASD2

GUDID 08717872013428

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

Surgical irrigation/aspiration tubing set

• Primary Device ID: 08717872013428
• NIH Device Record Key: 03455a9e-2e08-4388-be09-423d2442e836
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable I/A replacement Tubing set for REF: 6279.ASD1 Cartridge, including co
• Version Model Number: 6279.ASD2
• Catalog Number: 6279.ASD2
• 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	08717872013428 [Primary]
GS1	18717872013425 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081877

FDA Product Code

• HQC: Unit, Phacofragmentation

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: 2021-03-15
• Device Publish Date: 2016-09-23

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

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