A.M.I. HAL-II Electronic System - Electronic unit for identifying the localised - AMI Agency for Medical Innovations GmbH

Duns Number:303655286

Device Description: Electronic unit for identifying the localised haemorrhoidal arteries by means of acoustic Electronic unit for identifying the localised haemorrhoidal arteries by means of acoustic signals. Part of the A.M.I. HAL/RAR System.The A.M.I. HAL-II Electronic System is a Doppler-based device. It is powered by a DC voltage source (rechargeable batteries or 12 V adapter). The A.M.I. HAL-II Electronic System generates electrical signals, calculates differences between the wavelength of outgoing and reflected electrical signals, and generates an acoustic Doppler signal.Together with auxiliary A.M.I. devices (A.M.I. HAL Handle, Probe and Sleeve) the A.M.I. HAL-II Electronic System serves for the detection of haemorrhoidal arteries and enables manual ligation of detected arteries, as well as mucopexy of prolapsing haemorrhoidal mucosa.

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More Product Details

Catalog Number

AHE 203

Brand Name

A.M.I. HAL-II Electronic System

Version/Model Number

AHE 203

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 03, 2020

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K061831

Product Code Details

Product Code

IYN

Product Code Name

System, Imaging, Pulsed Doppler, Ultrasonic

Device Record Status

Public Device Record Key

07f416d1-6060-4d31-8547-444eab3b0894

Public Version Date

October 04, 2022

Public Version Number

5

DI Record Publish Date

November 28, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMI AGENCY FOR MEDICAL INNOVATIONS GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 47