A.M.I. EasyClinch Reusable Tips Premium ECI1020

GUDID EAMIECI10201

AMI Agency for Medical Innovations GmbH

Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable

• Primary Device ID: EAMIECI10201
• NIH Device Record Key: 9f38cf7b-cba1-4964-bf7d-fc436f2efc47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A.M.I. EasyClinch Reusable Tips Premium
• Version Model Number: ECI1020
• Catalog Number: ECI1020
• Company DUNS: 303655286
• Company Name: AMI Agency for Medical Innovations GmbH
• Device Count: 5
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 44 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EAMIECI10201 [Primary]
HIBCC	EAMIECI10202 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182013

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[EAMIECI10201]

Moist Heat or Steam Sterilization

[EAMIECI10201]

Moist Heat or Steam Sterilization

[EAMIECI10201]

Moist Heat or Steam Sterilization

[EAMIECI10201]

Moist Heat or Steam Sterilization

[EAMIECI10201]

Moist Heat or Steam Sterilization

[EAMIECI10201]

Moist Heat or Steam Sterilization

[EAMIECI10201]

Moist Heat or Steam Sterilization

[EAMIECI10201]

Moist Heat or Steam Sterilization

[EAMIECI10201]

Moist Heat or Steam Sterilization

[EAMIECI10201]

Moist Heat or Steam Sterilization

[EAMIECI10201]

Moist Heat or Steam Sterilization

[EAMIECI10201]

Moist Heat or Steam Sterilization

[EAMIECI10201]

Moist Heat or Steam Sterilization

[EAMIECI10201]

Moist Heat or Steam Sterilization

[EAMIECI10201]

Moist Heat or Steam Sterilization

[EAMIECI10201]

Moist Heat or Steam Sterilization

[EAMIECI10201]

Moist Heat or Steam Sterilization

[EAMIECI10201]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-15
• Device Publish Date: 2019-04-05

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