AccessGUDID - DEVICE: Sound Pro Table (00718175007105)

GUDID

Device Identifier (DI) Information

Brand Name: Sound Pro Table
Version or Model: 058-710
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 058-710
Company Name: BIODEX MEDICAL SYSTEMS, INC.

Primary DI Number: 00718175007105
Issuing Agency: GS1
Commercial Distribution End Date: July 24, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 043833813 *Terms of Use

Device Description: Table, Combination, Sound Pro, 115VAC

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?
40680	Multi-purpose diagnostic imaging table	An electrically-powered multi-purpose device intended to support and position a patient in conjunction with multiple diagnostic imaging procedures (e.g., x-ray, nuclear medicine or ultrasound). It may contain a variable number of articulated joints to facilitate patient positioning and incorporates electronic or software controls for table height, motion, and/or table top position.	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: 198ab8f5-d17c-47ab-87e6-a6cd07b6877a
Public Version Date: July 25, 2023
Public Version Number: 2
DI Record Publish Date: April 15, 2018