PHACO TIP WRENCH

GUDID 04049539100177

This re-usable device is an accessory for ZEISS phaco systems. It has been designed to screw and unscrew the tips to the phaco handpiece during human eye surgery.

Carl Zeiss Meditec AG

Ultrasonic surgical system torque wrench, reusable

• Primary Device ID: 04049539100177
• NIH Device Record Key: 825b4988-b8da-4f1b-a419-fe9cee95b612
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHACO TIP WRENCH
• Version Model Number: 303060-0121-000
• Company DUNS: 342228620
• Company Name: Carl Zeiss Meditec AG
• Device Count: 1
• 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: true
• 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	04049539100177 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212241

FDA Product Code

• NKX: Needle, Phacoemulsification, Reprocessed

Sterilization

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

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

[04049539100177]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-03
• Device Publish Date: 2022-04-25

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