Sanders Medical Products

Basic Information

• Brand Name: Sanders Medical Products
• Primary DI: 00850055164017
• Version / Model: PET-LINE
• Company Name: Sanders Medical Products, Inc.
• Labeler DUNS: 837530401
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-27
• Public Version: 1
• Public Version Date: 2023-08-04
• Public Version Status: New
• Public Device Record Key: ee65cd0f-6795-45c5-bed3-05d7d3ce5e0b

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
IXD	Source, Calibration, Sealed, Nuclear	Radiology	892.1400	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40608	Nuclear medicine phantom, line source	A device which is either a linear radioactive sealed source or refillable linear radiolucent tube to which radioactivity can be added. It is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of photon detector systems used in nuclear medicine imaging applications and associated image acquisition, display and analysis computer programs.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850055164017	GS1

Customer Contacts

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