AccessGUDID - DEVICE: IMAGE DIAGNOSTICS INC (00850977007027)

GUDID

Device Identifier (DI) Information

Brand Name: IMAGE DIAGNOSTICS INC
Version or Model: 100US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A100-1479
Company Name: IMAGE DIAGNOSTICS, INC.

Primary DI Number: 00850977007027
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 608235214 *Terms of Use

Device Description: IDI,TABLE,VERT. TABLETOP MOVEMENT,UROLOGY & IMAGING,ASPECT 100US,120V,NORTH AMERICA ACC'Y RAILS,#A100-1479

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?
40655	Basic diagnostic x-ray system table, powered	A powered/programmable table that is a component of a basic diagnostic x-ray system designed to position and support a patient during a variety of routine/planar or speciality diagnostic procedures requiring the use of a diagnostic x-ray system; it is not a planar tomography nor computed tomography (CT) table. It can be a stationary or mobile unit and is made of radiolucent materials with low x-ray attenuation coefficients. It is not intended for use during interventional radiology/surgery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MMZ	Table, Cystometric, Electric

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: 848da5ed-9deb-4862-abc7-466814fb949d
Public Version Date: June 09, 2023
Public Version Number: 3
DI Record Publish Date: February 24, 2017