ATOMLAB

Basic Information

• Brand Name: ATOMLAB
• Primary DI: 00718175000137
• Version / Model: 187-602
• Catalog Number: 187-602
• Company Name: BIODEX MEDICAL SYSTEMS, INC.
• Labeler DUNS: 043833813
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-16
• Public Version: 2
• Public Version Date: 2020-03-27
• Public Version Status: Update
• Public Device Record Key: d71ef908-9f9a-4b17-93c3-ecff9c81b956

Device Description

Thyroid Uptake System, Well Counter

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: 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
IZD	Probe, Uptake, Nuclear	Radiology	892.1320	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40648	Thyroid-uptake nuclear medicine system	An assembly of diagnostic devices that comprise a non-imaging nuclear medicine system designed primarily for radioactive iodine related thyroid uptake measurement and analysis applications. It can typically be upgraded with the addition of software and hardware for use in various quality assurance (QA) or radioimmunoassay laboratory applications, e.g., wipe-test assessment or Schilling tests. It typically includes a multichannel analyser, computer, scintillation detector, detector support equipment, an operator's console, video display, well counter detector, collimator, shielding, and application software.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00718175000137	GS1