| Primary Device ID | 15420045505926 |
| NIH Device Record Key | 86f345a3-32f6-4d9f-b01b-dc211000224d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Multicare Platinum |
| Version Model Number | 8-004-0017 |
| Catalog Number | 8-004-0017 |
| Company DUNS | 139534114 |
| Company Name | Hologic, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15420045505926 [Primary] |
| IZH | System, x-ray, mammographic |
| 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 | 2017-03-30 |
| 15420045517394 - Hologic | 2025-09-05 NG Res Primers Analyte Specific Reagent. |
| 15420045517400 - Hologic | 2025-09-05 NG Res Probe (FAM) Analyte Specific Reagent. |
| 15420045517417 - Hologic | 2025-09-05 NG Res C272T IVT Control (Positive Control). |
| 15420045517424 - Hologic | 2025-09-05 NG IVT Wild Type Control (Negative Control). |
| 15420045512412 - DEFINITY CERVICAL DILATOR, 5MM | 2025-07-29 |
| 15420045512429 - DEFINITY CERVICAL DILATOR, 7MM | 2025-07-29 |
| 15420045512436 - DEFINITY CERVICAL DILATOR, 9MM | 2025-07-29 |
| 15420045517097 - DIGITAL DIAGNOSTICS SYSTEM | 2025-07-25 Computer to operate the Genius™ Review Station. |