DIATHERMY FORCEPS

GUDID 04049539100504

This active re-usable device is an accessory for ZEISS phaco systems. It has been designed to cauterize (stop bleeding) small vessels during human eye surgery on the anterior segment.

Carl Zeiss Meditec AG

Endoscopic electrosurgical handpiece/electrode, bipolar, reusable

• Primary Device ID: 04049539100504
• NIH Device Record Key: fa483866-cbfc-4938-ac31-34a3d3757894
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIATHERMY FORCEPS
• Version Model Number: 303060-0251-000
• 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	04049539100504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212241

FDA Product Code

• HQR: Apparatus, Cautery, Radiofrequency, Ac-Powered

Sterilization

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

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

Moist Heat or Steam Sterilization

[04049539100504]

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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• 04049471100143 - Treatment Pack (Size M): 2024-02-19 single use accessory for ZEISS femtosecond lasers
• 04049471100150 - Treatment Pack (Size L): 2024-02-19 single use accessory for ZEISS femtosecond lasers