Featherlight micro Phaco emulsification/fragmentation handpiece. 3002.M

GUDID 08717872008899

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

Phacoemulsification system handpiece

• Primary Device ID: 08717872008899
• NIH Device Record Key: 7978a214-f85f-40c9-9bfe-ec026c297282
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Featherlight micro Phaco emulsification/fragmentation handpiece.
• Version Model Number: 3002.M
• Catalog Number: 3002.M
• Company DUNS: 407522184
• Company Name: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
• Device Count: 1
• 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	08717872008899 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190875

FDA Product Code

• HQC: Unit, Phacofragmentation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

[08717872008899]

Moist Heat or Steam Sterilization

[08717872008899]

Moist Heat or Steam Sterilization

[08717872008899]

Moist Heat or Steam Sterilization

[08717872008899]

Moist Heat or Steam Sterilization

[08717872008899]

Moist Heat or Steam Sterilization

[08717872008899]

Moist Heat or Steam Sterilization

[08717872008899]

Moist Heat or Steam Sterilization

[08717872008899]

Moist Heat or Steam Sterilization

[08717872008899]

Moist Heat or Steam Sterilization

[08717872008899]

Moist Heat or Steam Sterilization

[08717872008899]

Moist Heat or Steam Sterilization

[08717872008899]

Moist Heat or Steam Sterilization

[08717872008899]

Moist Heat or Steam Sterilization

[08717872008899]

Moist Heat or Steam Sterilization

[08717872008899]

Moist Heat or Steam Sterilization

[08717872008899]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-19
• Device Publish Date: 2016-09-23

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