FDA UDI
In Commercial Distribution
🇺🇸 United States
Globe Scientific
DI: 00840095600019
·
Model: 101020
·
GLOBE SCIENTIFIC INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1000
Basic Information
- Brand Name
- Globe Scientific
- Primary DI
- 00840095600019
- Version / Model
- 101020
- Company Name
- GLOBE SCIENTIFIC INC.
- Labeler DUNS
- 106793995
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2019-12-18
- Public Version
- 1
- Public Version Date
- 2019-12-26
- Public Version Status
- New
- Public Device Record Key
- 909ac80c-6299-4317-a743-86ea9f16da72
Device Description
Scintillation Vial, 6.5mL, PE, with Attached White Screw Cap
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38324 | Liquid scintillation counter | A precise radiation counting instrument designed to measure radioactivity emanating from a radioactive tracer on labelled samples. Primarily used to count beta particles, the radioactive sample is dissolved or suspended in an organic scintillation fluid where the emission of a beta particle causes the liquid to emit light which is detected and counted. The instrument typically consist of vials containing the radioactive samples and scintillation fluid, and electronics. It is typically applied as a detector for radioimmunoassay or immuno-radiometric assay for clinical use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840095600019 | GS1 | ||||
| Unit of Use | 00840095608541 | GS1 |