FDA UDI
In Commercial Distribution
🇺🇸 United States
Lara Sensor, Type 6
DI: 00850014578060
·
Model: D
·
LUCERNO DYNAMICS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Lara Sensor, Type 6
- Primary DI
- 00850014578060
- Version / Model
- D
- Catalog Number
- 401874-220-6
- 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
- 782982c2-c735-4c6d-b85a-42eb9b2e5e6b
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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 00850014578220 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 00850014578060 | GS1 |
Customer Contacts
- Phone
- 919-371-6800
- [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