REUSABLE BIPOLAR CORD LENGTH 12.0'

GUDID 00821925018938

Gyrus Acmi, Inc.

Electrosurgical system

• Primary Device ID: 00821925018938
• NIH Device Record Key: f81df61a-000f-40a2-917f-3e019e7d0dd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REUSABLE BIPOLAR CORD LENGTH 12.0'
• Version Model Number: 131509
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• 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: 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925018938 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K831236

FDA Product Code

• GEI: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

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

[00821925018938]

Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

[00821925018938]

Moist Heat or Steam Sterilization

[00821925018938]

Moist Heat or Steam Sterilization

[00821925018938]

Moist Heat or Steam Sterilization

[00821925018938]

Moist Heat or Steam Sterilization

[00821925018938]

Moist Heat or Steam Sterilization

[00821925018938]

Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

[00821925018938]

Moist Heat or Steam Sterilization

[00821925018938]

Moist Heat or Steam Sterilization

[00821925018938]

Moist Heat or Steam Sterilization

[00821925018938]

Moist Heat or Steam Sterilization

[00821925018938]

Moist Heat or Steam Sterilization

[00821925018938]

Moist Heat or Steam Sterilization

[00821925018938]

Moist Heat or Steam Sterilization

[00821925018938]

Moist Heat or Steam Sterilization

[00821925018938]

Moist Heat or Steam Sterilization

[00821925018938]

Moist Heat or Steam Sterilization

[00821925018938]

Moist Heat or Steam Sterilization

[00821925018938]

Moist Heat or Steam Sterilization

[00821925018938]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-28