DEVICE: Wi-3 Arm (EAMITRI20700)
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Device Identifier (DI) Information
Wi-3 Arm
TRI2070
In Commercial Distribution
TRI2070
AMI Agency for Medical Innovations GmbH
TRI2070
In Commercial Distribution
TRI2070
AMI Agency for Medical Innovations GmbH
The Wi-3 Arm is used to fix the outer (white) HAL-RAR sleeve in place to enhance gradual opening of the RAR window when mucopexy is performed, allowing the surgeon, the nurse or any assistant to comfortably hold the system in position.
The Wi-3 HAL-RAR System (HAL - Hemorrhoidal Artery Ligation, RAR - Recto Anal Repair) is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, to manually ligate these arteries (HAL), and subsequently carry out a mucopexy of hemorrhoidal tissue prolapse (RAR) if necessary.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 44311 | Noninvasive vascular ultrasound system |
An electrically-powered device assembly consisting of a control unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular (venous and arterial) flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. It may also be used to detect the foetal heartbeat.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic |
| FHN | Ligator, Hemorrhoidal |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
| Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature: between -20 and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
| Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature: between 10 and 35 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
f3649b49-dd42-450a-ac14-3e948fcb5e71
November 03, 2023
3
January 09, 2019
November 03, 2023
3
January 09, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined