AccessGUDID - DEVICE: Gonad Shield - set of 3

GUDID

Device Identifier (DI) Information

Brand Name: Gonad Shield - set of 3 - no closure
Version or Model: 806ARL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shielding International Inc.

Primary DI Number: G031806ARL0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009647322 *Terms of Use

Device Description: Gonad Shield - Plain - Set of 3 (S,M, L) - 0.5mm Regular Lead (RL)

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?
38367	Gonad radiation shield	A personal protective device intended to shield the gonads of an individual (i.e., a device operator, patient, or other attending person) from unnecessary exposure to radiation from diagnostic medical and dental procedures by providing an attenuating barrier to the radiation. It comes in various configurations: 1) anatomically designed to fit over the gonads; 2) placed directly on the body; or 3) attached to the wall or radiation delivery device on an articulating arm. Radiation protection male and female gonadal shields are typically made of lead (Pb) or lead-equivalent material.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IWT	Shield, Gonadal

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: 0435dd7c-91ef-4363-bc4c-277224bcd382
Public Version Date: October 20, 2023
Public Version Number: 1
DI Record Publish Date: October 12, 2023