AccessGUDID - DEVICE: Sound Pro Combination Ultrasound Table, 115V (00879942070613)

GUDID

Device Identifier (DI) Information

Brand Name: Sound Pro Combination Ultrasound Table, 115V
Version or Model: 058-710
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 058-710
Company Name: Mirion Technologies (capintec), Inc.

Primary DI Number: 00879942070613
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 047684501 *Terms of Use

Device Description: Fully equipped for OB/GYN, general ultrasound and echocardiography procedures with extra-wide tabletop and cardiac cut outs. Includes hand and foot controllers to activate height, Trendelenburg motions and Fowler positioning.

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):	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?
62694	Ultrasound imaging system table, powered	An electrically-powered flat or curved-top table specifically designed to position and support a patient during diagnostic procedures involving the use of an ultrasound imaging system; it is not primarily intended for interventional procedures/surgery or x-ray imaging. It has electronic and/or software controls for tabletop height and positioning.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQO	Table, Operating-Room, Ac-Powered

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: 6474f49b-6e49-4f3b-b08e-faa6722ef937
Public Version Date: July 24, 2023
Public Version Number: 1
DI Record Publish Date: July 14, 2023