Lara System, 140 keV

Basic Information

• Brand Name: Lara System, 140 keV
• Primary DI: 00850014578121
• Version / Model: G
• Catalog Number: 401874-100-2
• Company Name: LUCERNO DYNAMICS, LLC
• Labeler DUNS: 078821264
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-01
• Public Version: 1
• Public Version Date: 2023-01-09
• Public Version Status: New
• Public Device Record Key: 7b9c59a2-19e4-4751-b5d9-6596db07e153

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
38332	Scintillation-counter radiation survey meter	A gamma ray, x-ray, neutron, alpha, and beta radiation counting instrument that measures scintillation light (or prompt fluorescence) produced by the interaction of the ionizing radiation and certain materials. A wide variety of inorganic crystals and plastics (liquid scintillators dissolved in a solvent and polymerized) can produce scintillation light. Material used will determine the kind of radiation measured and some can be used in severe environmental conditions unsuitable for other survey meters. It may include portable survey meters and stationary area monitors and consist of a radiation detection chamber, light sensor, power supply, controls, read out mechanism.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850014578121	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 45 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Storage Environment Temperature
• Temperature Range: -20 – 30 Degrees Celsius