| Primary Device ID | 25420045501086 |
| NIH Device Record Key | 1d75828a-9956-4297-8da4-8d0df27b12dd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ThinPrep Pap Test |
| Version Model Number | ThinPrep Pap Test Filters |
| Company DUNS | 018925968 |
| Company Name | Hologic, Inc. |
| Device Count | 100 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Handling Environment Temperature | Between 0 and 15 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 15 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15420045501089 [Unit of Use] |
| GS1 | 25420045501086 [Primary] |
| GS1 | 35420045501083 [Package] Contains: 45420045501080 Package: BOX [1 Units] In Commercial Distribution |
| GS1 | 45420045501080 [Package] Package: BOX [5 Units] In Commercial Distribution |
| MKQ | Processor, cervical cytology slide, automated |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-12 |
| 25420045501109 | ThinPrep Microscope Slides |
| 25420045501086 | ThinPrep Pap Test Filters |
| 15420045504011 | ThinPrep Pap Test Physician Kit |
| 15420045504004 | ThinPrep Pap Test Physician Kit |
| 15420045501072 | ThinPrep Pap Test PreservCyt Solution |
| 15420045514652 | ThinPrep Pap Test PreservCyt Solution |
| 15420045514683 | ThinPrep Pap Test Filters |