AccessGUDID - DEVICE: Wi-3 HAL-RAR Unit (EAMITRI20100)

GUDID

Device Identifier (DI) Information

Brand Name: Wi-3 HAL-RAR Unit
Version or Model: TRI2010
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: TRI2010
Company Name: AMI Agency for Medical Innovations GmbH

Primary DI Number: EAMITRI20100
Issuing Agency: HIBCC
Commercial Distribution End Date: April 10, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 303655286 *Terms of Use

Device Description: Electronic unit for identifying the localised haemorrhoidal arteries by means of acoustic signals. Part of the Wi-3 HAL-RAR System. 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

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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.	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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam 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 Temperature: 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
Height: 7 Centimeter
Outer Diameter: 23 Centimeter

Device Record Status

Public Device Record Key: b5416b5d-7b1f-4218-b480-79326eb07c8e
Public Version Date: November 03, 2023
Public Version Number: 3
DI Record Publish Date: January 09, 2019