A.M.I. HAL Handle AHH 001

GUDID EAMIAHH0010

Handle for the HAL/RAR probes.

AMI Agency for Medical Innovations GmbH

Noninvasive vascular ultrasound system, battery-powered Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system

• Primary Device ID: EAMIAHH0010
• NIH Device Record Key: e1c05905-b807-4e76-a538-1150e1a77684
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A.M.I. HAL Handle
• Version Model Number: AHH 001
• Catalog Number: AHH 001
• Company DUNS: 303655286
• Company Name: AMI Agency for Medical Innovations GmbH
• 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: true
• Manufacturing Date: true
• 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
HIBCC	EAMIAHH0010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061831

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

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

[EAMIAHH0010]

Moist Heat or Steam Sterilization

[EAMIAHH0010]

Moist Heat or Steam Sterilization

[EAMIAHH0010]

Moist Heat or Steam Sterilization

[EAMIAHH0010]

Moist Heat or Steam Sterilization

[EAMIAHH0010]

Moist Heat or Steam Sterilization

[EAMIAHH0010]

Moist Heat or Steam Sterilization

[EAMIAHH0010]

Moist Heat or Steam Sterilization

[EAMIAHH0010]

Moist Heat or Steam Sterilization

[EAMIAHH0010]

Moist Heat or Steam Sterilization

[EAMIAHH0010]

Moist Heat or Steam Sterilization

[EAMIAHH0010]

Moist Heat or Steam Sterilization

[EAMIAHH0010]

Moist Heat or Steam Sterilization

[EAMIAHH0010]

Moist Heat or Steam Sterilization

[EAMIAHH0010]

Moist Heat or Steam Sterilization

[EAMIAHH0010]

Moist Heat or Steam Sterilization

[EAMIAHH0010]

Moist Heat or Steam Sterilization

[EAMIAHH0010]

Moist Heat or Steam Sterilization

[EAMIAHH0010]

Moist Heat or Steam Sterilization

[EAMIAHH0010]

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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