AccessGUDID - DEVICE: Quick Release Thyroid Collar (G031631QRSRL0)

GUDID

Device Identifier (DI) Information

Brand Name: Quick Release Thyroid Collar
Version or Model: 631QRSRL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shielding International Inc.

Primary DI Number: G031631QRSRL0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009647322 *Terms of Use

Device Description: Quick Release Thyroid Collar 631QR Small - 24" L - 0.5mm Reg 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?
38358	Radiation shielding collar	A personal protective device intended to shield the neck area including the nape, the throat, and the thyroid of an individual (i.e., a device operator or other attending person) from unnecessary exposure to radiation during diagnostic or therapeutic medical and dental procedures. Collars used in x-ray and nuclear medicine typically consist of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Collars used for neutron attenuation are composed of hydrogenous materials instead of lead; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials. This is a reusable device.	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: 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: bcbacb9d-a8ce-4361-9f66-1e0941bfda8f
Public Version Date: October 20, 2023
Public Version Number: 1
DI Record Publish Date: October 12, 2023