AccessGUDID - DEVICE: IMAGE DIAGNOSTICS INC (00850977007133)

GUDID

Device Identifier (DI) Information

Brand Name: IMAGE DIAGNOSTICS INC
Version or Model: ISR G2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: A100-1902
Company Name: IMAGE DIAGNOSTICS, INC.

Primary DI Number: 00850977007133
Issuing Agency: GS1
Commercial Distribution End Date: April 03, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 608235214 *Terms of Use

Device Description: IDI,TABLE,VERT.-TILT-ROLL-HORIZ. TABLETOP MOVEMENT,VASCULAR-INTERVENTIONAL-IMAGING,ASPECT ISR G2,120V,STANDARD TABLETOP,NORTH AMERICA ACC'Y RAILS,#A100-1902

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
IXR	Table, Radiographic, Tilting

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: e61bba16-2b93-4a5c-b6ca-de03b80c321d
Public Version Date: June 08, 2023
Public Version Number: 3
DI Record Publish Date: December 27, 2016