SRC PHANTOM CS 20-2 GE68 2 MCI PLYU

Basic Information

• Brand Name: SRC PHANTOM CS 20-2 GE68 2 MCI PLYU
• Primary DI: 04056869002583
• Version / Model: 10239097
• Catalog Number: P0020289
• Company Name: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Labeler DUNS: 111494907
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-24
• Public Version: 3
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: bc320168-5544-458e-8e89-4eb4c35760e9

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
IYQ	Phantom, flood source, nuclear	Radiology	892.1380	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40630	Nuclear medicine phantom, test object	A device that includes a wide variety of two or three-dimensional (3-D) phantoms used in both calibration protocols and in subjective and quantitative evaluations of the performance of diagnostic nuclear medicine (NM) detector systems, e.g., gamma cameras, single photon emission computed tomography (SPECT), positron emission tomography (PET) or associated image display system and software programs. It consists of either fixed or variable configurations or patterns of absorbing or attenuating materials and radioactive source holders. The design can incorporate radioactive sealed sources or refillable radioactive source wells to which radioactivity can be added.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04056869002583	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Radioactive sources should be stored in a designated area which is secure & provides adequate shielding.Records which conform to local regulatory requirements are required for all radioactive sources.