AccessGUDID - DEVICE: IMAGE DIAGNOSTICS, INC (00850061871107)

GUDID

Device Identifier (DI) Information

Brand Name: IMAGE DIAGNOSTICS, INC
Version or Model: FEMORAL SHIELD RADIATION SHIELD PAD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: X800-0251
Company Name: IMAGE DIAGNOSTICS, INC.

Primary DI Number: 00850061871107
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 15
Labeler D-U-N-S® Number*: 608235214 *Terms of Use

Device Description: IDI,PROTEGO,PAD,SCATTER SHIELD,FEMORAL,CASE OF 15,#X800-0251

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:	Yes
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?
38373	Radiation shielding panel, portable/mobile	A portable or mobile rigid barrier designed to shield patients and healthcare professionals from unnecessary exposure to radiation used in diagnostic or therapeutic medical procedures. It provides a physical radiation-attenuating barrier between an individual and a source of primary or scattered radiation. It may be a stand-alone device or intended to be integrated within an electronic system; the panel itself is not electronic. The types of materials used depend on the type of radiation to be attenuated [e.g., those used in diagnostic x-ray and nuclear medicine consist of lead (Pb) or lead-equivalent materials, and those used to attenuate neutrons are composed of hydrogenous materials].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPY	Shield, Protective, Personnel

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: Yes
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: 6fd5f6dd-20bf-4d3d-9b55-21f20aad55e5
Public Version Date: October 31, 2024
Public Version Number: 1
DI Record Publish Date: October 23, 2024