AccessGUDID - DEVICE: FusionMAX Spine Table (00840343716424)

GUDID

Device Identifier (DI) Information

Brand Name: FusionMAX Spine Table
Version or Model: 33501
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SURGIX MEDICAL LLC

Primary DI Number: 00840343716424
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080402644 *Terms of Use

Device Description: The FusionMAX™ Table is a mobile surgery table designed for temporary support (<24 hours) and positioning of a patient in a prone, supine, or lateral position. The Table is intended for use during surgical procedures, including radiographic imaging during such procedures. The Table is not intended for use in patient transport.

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):	Yes
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?
45400	Orthopaedic operating table, electromechanical	A mobile, electrically-powered motorized table designed to support a patient and to provide traction for the limb(s)/spine of the patient during orthopaedic surgical procedures. Its surface consists of articulated sections that can be adjusted, and it is often intended to be used with additional patient positioners. It may have x-ray transparent features.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JEA	Table, Surgical With Orthopedic Accessories, 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
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 15 and 120 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6822d7ae-622b-4b29-9910-292e33b3c9fa
Public Version Date: April 14, 2023
Public Version Number: 1
DI Record Publish Date: April 06, 2023