AccessGUDID - DEVICE: Capintec Neck Phantom (00859942006324)

GUDID

Device Identifier (DI) Information

Brand Name: Capintec Neck Phantom
Version or Model: 5230-0038
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5230-0038
Company Name: Mirion Technologies (capintec), Inc.

Primary DI Number: 00859942006324
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 047684501 *Terms of Use

Device Description: Thyroid Uptake Neck Phantom

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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYP	Phantom, Anthropomorphic, Nuclear

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: c72a8c92-beee-4392-a5e7-7a1c237c2960
Public Version Date: December 14, 2022
Public Version Number: 2
DI Record Publish Date: July 01, 2019