AccessGUDID - DEVICE: Lara System, 511 keV (00850014578114)

GUDID

Device Identifier (DI) Information

Brand Name: Lara System, 511 keV
Version or Model: G
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 401874-100-1
Company Name: LUCERNO DYNAMICS, LLC

Primary DI Number: 00850014578114
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078821264 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IZD	Probe, Uptake, Nuclear

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 32c533e7-7a00-49a4-ba74-90015053bcf4
Public Version Date: January 09, 2023
Public Version Number: 1
DI Record Publish Date: January 01, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 919-371-6800
Email: info@lucerno.com

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