Vented Global Pressure Control Set to be used with Associate Cartridge 1250.VGPC

GUDID 08717872017594

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

Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set

• Primary Device ID: 08717872017594
• NIH Device Record Key: 8c732d1f-7646-4050-a094-318c0db31729
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vented Global Pressure Control Set to be used with Associate Cartridge
• Version Model Number: 1250.VGPC
• Catalog Number: 1250.VGPC
• 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	08717872017594 [Primary]
GS1	18717872007592 [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

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