FDA.reportPublic FDA data

Lara System, 140 keV

Primary DI
00850014578121
Brand
Lara System, 140 keV
Company
LUCERNO DYNAMICS, LLC
Model
G
Catalog number
401874-100-2
Published
2023-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IZDProbe, Uptake, Nuclear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZDProbe, Uptake, NuclearRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850014578121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014578121008500145781218500145781210850014578121

GMDN Terms#

Term, Definition table
TermDefinition
Scintillation-counter radiation survey meterA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity45 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature-20 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
919-371-6800info@lucerno.com

Regulatory Flags#

DUNS number
078821264
Device count
1
Premarket exempt
true
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014578008Lara ReaderB401874-2302023-01-01
00850014578015Lara Sensor, Type 1D401874-220-12023-01-01
00850014578022Lara Sensor, Type 2D401874-220-22023-01-01
00850014578039Lara Sensor, Type 3D401874-220-32023-01-01
00850014578046Lara Sensor, Type 4D401874-220-42023-01-01
00850014578053Lara Sensor, Type 5D401874-220-52023-01-01
00850014578060Lara Sensor, Type 6D401874-220-62023-01-01
00850014578077Lara Sensor, Type 7D401874-220-72023-01-01
00850014578084Lara Sensor, Type 8D401874-220-82023-01-01
00850014578091Lara QC Fixture2401874-2002023-01-01
00850014578107Lara Docking StationB401874-2852023-01-01
00850014578114Lara System, 511 keVG401874-100-12023-01-01
00850014578145Sensor Pad091220-018091220-0182021-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841911103615NeoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2025-07-28
00841911103622NeoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2025-07-28
B619K0018C01UP0GammaPro Straight Standard ProbeKubtecIZD2025-03-26
B619K0019C01UW0GammaPro High Sensitivity ProbeKubtecIZD2025-03-26
B619K0020C01TA0GammaPro Laparoscopic ProbeKubtecIZD2025-03-26
B619K0021C01TH0GammaPro Angled Standard ProbeKubtecIZD2025-03-26
00841911102526neoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2024-09-16
00841911102533neoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2024-09-16
00841911102540neoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2024-09-16
00841911102557neoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2024-07-31
04260152884415Navigator 3 Wired Probe, 13mm Straightcrystal-photonics GmbHIZD2024-03-19
04260152884422Navigator 3 Wired Probe Cablecrystal-photonics GmbHIZD2024-03-19
04260152884484Navigator 3 Wired Probe, 14 mm Angledcrystal-photonics GmbHIZD2024-03-19
04260152884491Navigator 3 WirelessPprobe, 13mm Straightcrystal-photonics GmbHIZD2024-03-19
04260152884507Navigator 3 Wireless Probe, 14 mm Angledcrystal-photonics GmbHIZD2024-03-19
04260152884514Navigator 3 Wireless Probe Battery Packcrystal-photonics GmbHIZD2024-03-19
04260152887102Navigator 3 Control Unitcrystal-photonics GmbHIZD2024-03-19
00860008268907Node Seeker 2000INTRA MEDICAL IMAGING LLCIZD2023-05-03
08437018413294GAMMAPROGENERAL EQUIPMENT FOR MEDICAL IMAGING SAIZD2023-01-18
B939CW5APO1050CareWiseSOUTHERN SCIENTIFIC LIMITEDIZD2023-01-16
B939CW5APO1060CareWiseSOUTHERN SCIENTIFIC LIMITEDIZD2023-01-16
00850014578008Lara ReaderLUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578015Lara Sensor, Type 1LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578022Lara Sensor, Type 2LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578039Lara Sensor, Type 3LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578046Lara Sensor, Type 4LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578053Lara Sensor, Type 5LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578060Lara Sensor, Type 6LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578077Lara Sensor, Type 7LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578084Lara Sensor, Type 8LUCERNO DYNAMICS, LLCIZD2023-01-01