AccessGUDID - DEVICE: IMAGE DIAGNOSTICS, INC (00850061871190)

GUDID

Device Identifier (DI) Information

Brand Name: IMAGE DIAGNOSTICS, INC
Version or Model: Protego ProLite System for Siemens Icono Tables
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A800-0471-SII
Company Name: IMAGE DIAGNOSTICS, INC.

Primary DI Number: 00850061871190
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 608235214 *Terms of Use

Device Description: IDI,RADIATION SHIELD SYSTEM,PROTEGO,PROLITE TABLE MOUNT,METRIC ACCESSORY RAILS,SIEMENS ICONO TABLE#A800-0471-SII

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?
38375	Radiation shielding curtain	A flexible radiation protective device intended to shield the operator or other attending persons from unnecessary exposure to radiation emitted during a medical or dental procedure. The curtain is a flexible radiation blocking or attenuating barrier located between the individual and the source of primary or scattered radiation. This radiation barrier is designed to hang from rods or tracks attached to the ceiling, wall, radiation delivery equipment, or other radiation shields. It typically consists of a fluid resistant outer covering that surrounds a thin sheet of flexible lead (Pb) or lead-equivalent material.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IWQ	Curtain, Protective, Radiographic

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: 8a27fcb4-2d85-4506-b77c-62c62a3c6ecf
Public Version Date: May 07, 2025
Public Version Number: 1
DI Record Publish Date: April 29, 2025