FDA UDI
In Commercial Distribution
🇺🇸 United States
ThinPrep
DI: 15420045508354
·
Model: CellFyx Device
·
Hologic, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ThinPrep
- Primary DI
- 15420045508354
- Version / Model
- CellFyx Device
- Catalog Number
- 70215-001
- Company Name
- Hologic, Inc.
- Labeler DUNS
- 018925968
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-30
- Public Version
- 2
- Public Version Date
- 2019-06-07
- Public Version Status
- Update
- Public Device Record Key
- 56a3da82-e040-445a-b93c-e46f6e119970
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
- Yes
- 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 |
|---|---|---|---|---|
| PPM | General purpose reagent | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57743 | Cytology fixative solution IVD | An alcohol-based solution intended to be used as a fixative for a cytology specimen obtained directly from a patient, or processing of a clinical specimen, for subsequent preservation, transportation and/or in vitro diagnostic analysis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15420045508354 | GS1 |