AccessGUDID - DEVICE: SONOPRO (00860009496903)

GUDID

Device Identifier (DI) Information

Brand Name: SONOPRO
Version or Model: 0002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SONO-0002
Company Name: Restec Solutions LLC

Primary DI Number: 00860009496903
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038833403 *Terms of Use

Device Description: SONOPRO is a limited pre-production run of Automated Disinfector Devices. It is classified by the FDA as a Class II medical device, product code MEC. It is intended for use in the critical care areas of the hospital clinical setting, disinfecting Spaulding category low-risk hand-held re-useable medical devices. Devices must be first pre-cleaned or free of visible bioburden.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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):	No
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?
66654	Atomized-chemical device disinfector	An electrically-powered unit designed for the disinfection of devices at the point-of-use using ultrasonically generated ultra-fine particle aerosolized disinfectant. It consists of a cabinet (e.g., with internal shelves) intended to accept pre-cleaned medical devices/equipment (including electrical devices), an ultrasonic disinfectant atomizer and a control panel. It is intended to be used as an alternative to wipe down disinfection, and is not intended for use in a reprocessing suite.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MEC	Disinfector, Medical Devices

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 16411e7e-7d6a-4e52-ac2a-bfe2d2e8e0b5
Public Version Date: June 06, 2024
Public Version Number: 2
DI Record Publish Date: March 31, 2023