FDA UDI
In Commercial Distribution
🇺🇸 United States
Microscope Slides, 1/2G, uncoated, Cytopro Dual
DI: 03661540303180
·
Model: SS-117
·
ELITECHGROUP INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Microscope Slides, 1/2G, uncoated, Cytopro Dual
- Primary DI
- 03661540303180
- Version / Model
- SS-117
- Catalog Number
- SS-217
- Company Name
- ELITECHGROUP INC.
- Labeler DUNS
- 052423787
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-14
- Public Version
- 2
- Public Version Date
- 2023-10-02
- Public Version Status
- Update
- Public Device Record Key
- bda2328c-c14b-42ef-a0b2-072798073a54
Device Description
Microscope Slides, 1/2G, uncoated, Cytopro Dual. Slides are used to collect the material centrifuged out of the solutions contained in the sample chambers. Slides are designed specifically for single, double, or magnum chambers and come in coated and uncoated versions for each.
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35881 | Cytological centrifuge IVD | An electrically-powered device intended to be used in a clinical laboratory setting to separate the cellular components of suspensions in a clinical specimen through centrifugal force for subsequent cytological analysis. It is typically a compact unit with an electric motor, a vertical shaft, and a special horizontal rotor attached that enables cells to be separated from a liquid suspension and deposited directly onto a microscope slide for microscopic examination. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03661540303180 | GS1 |