FDA UDI
In Commercial Distribution
🇺🇸 United States
ThinPrep®
DI: 15420045508316
·
Model: ThinPrep® PreservCyt® Sol'n 20ml
·
Hologic, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- ThinPrep®
- Primary DI
- 15420045508316
- Version / Model
- ThinPrep® PreservCyt® Sol'n 20ml
- Catalog Number
- 70097-002
- 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
- 5
- Public Version Date
- 2024-04-11
- Public Version Status
- Update
- Public Device Record Key
- c3fa995e-6438-427c-bfe3-43d4dbec0519
Device Description
For use with the ThinPrep® system to preserve non-gynecological specimens.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LEA | PRESERVATIVE, CYTOLOGICAL | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47775 | General specimen container IVD, no additive/medium | An empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15420045508316 | GS1 | ||||
| Package | 25420045508313 | GS1 | TRAY | 25 | In Commercial Distribution | |
| Package | 35420045508310 | GS1 | BOX | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)442-9892
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius