White infusion sleeve for 3005.FDS phaco needles 3003.S

GUDID 08717872008974

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

Phacoemulsification system handpiece

• Primary Device ID: 08717872008974
• NIH Device Record Key: 9a4b9158-ee7d-42f1-933f-245451795d5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: White infusion sleeve for 3005.FDS phaco needles
• Version Model Number: 3003.S
• Catalog Number: 3003.S
• Company DUNS: 407522184
• Company Name: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
• Device Count: 5
• DM Exempt: true
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	08717872008974 [Primary]
GS1	18717872008964 [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: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-08
• Device Publish Date: 2016-09-23

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

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