Capintec Neck Phantom

Basic Information

• Brand Name: Capintec Neck Phantom
• Primary DI: 00859942006324
• Version / Model: 5230-0038
• Catalog Number: 5230-0038
• Company Name: Mirion Technologies (capintec), Inc.
• Labeler DUNS: 047684501
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-01
• Public Version: 2
• Public Version Date: 2022-12-14
• Public Version Status: Update
• Public Device Record Key: c72a8c92-beee-4392-a5e7-7a1c237c2960

Device Description

Thyroid Uptake Neck Phantom

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYP	Phantom, Anthropomorphic, Nuclear	Radiology	892.1370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33115	Nuclear medicine phantom, anthropomorphic	A device that consists of preserved human or animal tissue, or a two or three-dimensional (3-D) tissue-equivalent model designed to mimic the functional, physical, or a combination of these characteristics of normal or diseased human organs. It is used in diagnostic nuclear medicine and incorporates radioactive sealed sources or refillable cavities to which radioactivity can be added in order to simulate anticipated in vivo distributions of radiopharmaceuticals used in nuclear medicine imaging procedures. It is a quality assurance (QA) device permitting both subjective and quantitative evaluation of the overall function of photon detector systems, e.g., gamma camera, SPECT or PET.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859942006324	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]