FDA UDI
In Commercial Distribution
🇺🇸 United States
Non Gyn Only ThinPrep Genesis Processor
DI: 15420045512481
·
Model: Non Gyn Only ThinPrep Genesis Processor
·
Hologic, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Non Gyn Only ThinPrep Genesis Processor
- Primary DI
- 15420045512481
- Version / Model
- Non Gyn Only ThinPrep Genesis Processor
- Catalog Number
- PRD-04952
- Company Name
- Hologic, Inc.
- Labeler DUNS
- 018925968
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-31
- Public Version
- 1
- Public Version Date
- 2020-08-10
- Public Version Status
- New
- Public Device Record Key
- bc4a616a-c755-4483-a172-3e9ff0f98477
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| IFB | CYTOCENTRIFUGE | Pathology | 864.3300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15110 | Microscope slide maker IVD | An automated mains electricity (AC-powered) laboratory instrument intended to be used to prepare, transfer and/or fix blood, tissue or other clinical specimens onto microscope examination slides so they are suitable for subsequent staining and/or microscopic analysis. The device operates with minimal technician involvement and complete automation of all procedural steps. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15420045512481 | GS1 |